A Phase 1 clinical trial is the first test of an investigational drug in humans. “Phase 1 trial services” is the industry phrase for the work built around that test. Federal regulation defines the study, the parties who run it, and the application that must be on file first. Save My Fat does not provide these services. This guide is education only.
TLDR Phase 1 is the first introduction of an investigational drug into humans. Under 21 CFR 312.21 it generally runs 20 to 80 participants, while FDA patient materials cite 20 to 100. Sponsors initiate, investigators conduct, and contract research organizations take on sponsor duties only in writing. Save My Fat provides no such services, and banking adipose tissue does not guarantee eligibility, access, or clinical benefit.
Important Disclaimer: Save My Fat does not provide FDA-approved treatments or cures for any disease. Banking adipose tissue today does not guarantee eligibility, access, or clinical benefit from any future therapy, clinical trial, or medical program. No adipose-derived stem cell product currently has FDA approval for any condition. All content is for educational purposes only and does not constitute medical advice. Patients must consult their own licensed healthcare professionals regarding all medical decisions.
Two very different readers search this phrase. One is a sponsor or physician asking what an early study requires. The other is a patient who saw a phase number on a product.
Both answers sit in federal regulation. FDA defines the phases at 21 CFR 312.21, where a number marks a stage of development, not a verdict.
What happens during a Phase 1 study
Phase 1 is “the initial introduction of an investigational new drug into humans,” and its job is safety and dosing. These studies are designed to determine “the metabolism and pharmacologic actions of the drug in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness.”
Participants are not always sick, since Phase 1 “may be conducted in patients or normal volunteer subjects.” The group is small. Section 312.21 puts the total “generally in the range of 20 to 80.” FDA’s patient-facing table cites 20 to 100 over several months. The two figures do not match, and both are FDA’s own.
How a Phase 1 clinical trial differs from Phase 2 and Phase 3
Size, purpose, and duration all grow as a program advances. Phase 2 tests effectiveness for a particular indication, “usually involving no more than several hundred subjects.” Phase 3 runs “from several hundred to several thousand subjects.” FDA’s patient materials supply the figures below.
| Phase | Participants | Purpose | Length | Advance rate |
|---|---|---|---|---|
| Phase 1 | 20 to 100 volunteers or patients | Safety and dosage | Several months | About 70 percent |
| Phase 2 | Up to several hundred patients | Efficacy and side effects | Several months to 2 years | About 33 percent |
| Phase 3 | 300 to 3,000 patients | Efficacy and adverse reactions | 1 to 4 years | About 25 to 30 percent |
Those rates apply one step at a time, and Phase 4 follows approval. FDA publishes no overall figure for the share of drugs entering Phase 1 that win approval, so multiplying them is arithmetic, not an FDA statistic.
Who provides Phase 1 trial services
Sponsors, investigators, and contractors do, and 21 CFR 312.3 defines each. A sponsor “takes responsibility for and initiates a clinical investigation” and may be a company, an agency, or an academic institution. A sponsor also “does not actually conduct the investigation unless the sponsor is a sponsor-investigator.”
An investigator is “an individual who actually conducts a clinical investigation.” A contract research organization “assumes, as an independent contractor with the sponsor, one or more of the obligations of a sponsor.” Section 312.52 requires that transfer in writing: “Any obligation not covered by the written description shall be deemed not to have been transferred.”
“Dedicated Phase 1 unit” is industry terminology, not an FDA-defined or FDA-certified category. The accurate description is a clinical research site running Phase 1 studies under a sponsor’s IND. This article names no company, and Save My Fat provides none of this work.
The application that has to exist first
No Phase 1 study starts without an investigational new drug application, or IND. FDA’s IND application page explains: “Current Federal law requires that a drug be the subject of an approved marketing application before it is transported or distributed across state lines.”
Then a clock runs. “Once the IND is submitted, the sponsor must wait 30 calendar days before initiating any clinical trials,” FDA writes. The agency uses that time to review for safety. Contents sit at 21 CFR 312.23, and FDA keeps an IND Navigator for sponsors.
How to verify a phase on ClinicalTrials.gov, and what it does not prove
Check the record’s phase value against the registry’s own definitions. The ClinicalTrials.gov glossary states: “There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.”
Early Phase 1 sits before traditional Phase 1 and involves “very limited human exposure to the drug.” Our guide to registry phase labels covers each value.
A listing is not a clearance. FDA states on its consumer information page: “The inclusion of a product in the clinicaltrials.gov database or the fact that a firm has registered with FDA and listed its product does not mean the product is legally marketed.”
So read a phase number as a stage, not a result. Adipose tissue and anything derived from it stays investigational and is not FDA approved for any disease. FDA’s consumer alert lists conditions for which no regenerative medicine product is approved.
Frequently Asked Questions
Does Save My Fat provide Phase 1 trial services?
No. Save My Fat does not sponsor studies, conduct studies, or enroll patients. It is not a clinic or a medical practice.
What does Not Applicable mean on a study listing?
The registry uses it for trials without FDA-defined phases, including device and behavioral trials. It signals that the drug phase framework does not apply, not that a phase was skipped.
How does a patient get into a study?
Through the study’s own protocol and its investigators, a route our guide to clinical trial enrollment covers. Banking tissue places no one in a study, and eligibility questions belong with a licensed healthcare professional.
Key Takeaways
Phase 1 is the first human test of an investigational drug, aimed at safety and dosing. The regulation says generally 20 to 80 participants and FDA’s patient materials say 20 to 100. Sponsors initiate, investigators conduct, and contract research organizations take on only the duties a written transfer names. A dedicated Phase 1 unit is industry language, not an FDA category. Every study needs an IND first. Phase labels describe stage, not proof, and Save My Fat does not provide these services.
Save My Fat operates as a tissue preservation service, not a medical practice or treatment provider. Stem cell and regenerative medicine regulations vary by state, including specific informed-consent and disclosure requirements in Florida, Utah, and Nevada governing tissue and stem cell services. Banking adipose tissue does not connect patients to any treatment pathway, and any future use depends on FDA regulatory status, physician guidance, and the availability of approved or investigational pathways at that time.
Readers weighing adipose tissue banking for potential future use can compare current pricing or bring a question to the contact page.
Save My Fat partners with L2 Bio for laboratory processing and storage.
This article is for educational purposes only and does not constitute medical or legal advice. Legal and medical review including neurology and neurosurgery input is required before publication. Please consult your neurologist or neurosurgeon before making any decisions about adipose tissue banking or research participation.
About the author: Oscar Tellez is the founder and CEO of Save My Fat. He holds a Bachelor of Science in Exercise Science and Health Promotion from Florida Atlantic University. He has spent more than a decade in the regenerative medicine industry across product distribution, laboratory and vendor relationships, and provider training. He is not a licensed clinician, and this article is educational, not medical advice.
Related guide: adipose stem cell trials.
