Plan your Phase 1 trial from IND to Phase 2
Start from your IND-enabling package or from a draft first-in-human protocol.
Compare typical durations, deliverables and prerequisites for every step, from starting dose selection and the 30-day IND review to SAD and MAD cohorts and the clinical study report.
Set a realistic first-in-human timeline and know what your team must deliver before each dose escalation.
Review the program at a glance
- 1. IND-Enabling Hand-off and Program Strategy2-3 months
- 2. Protocol, Investigator's Brochure and Study Documents2-4 months
- 3. IND Submission and FDA Review2-3 months
- 4. Phase 1 Unit Selection, Ethics and Site Activation2-4 months
- 5. Single Ascending Dose (SAD)3-6 months
- 6. Multiple Ascending Dose (MAD)4-8 months
- 7. Safety Monitoring and ReportingThroughout the study
- 8. Bioanalysis, Database Lock and Clinical Study Report4-6 months
- 9. End of Phase 1 and Transition to Phase 22-4 months
Stage 1: IND-Enabling Hand-off and Program Strategy
Confirm that the nonclinical and CMC packages support first-in-human dosing, set the starting dose, and agree the clinical development plan before protocol writing starts.
Stage 2: Protocol, Investigator's Brochure and Study Documents
Write the first-in-human protocol, the Investigator's Brochure and the documents that sites, ethics committees and the regulator need.
Stage 3: IND Submission and FDA Review
Assemble and submit the IND, then wait the 30-day review period before dosing in the US.
Stage 4: Phase 1 Unit Selection, Ethics and Site Activation
Choose the Phase 1 unit and labs, get IRB or ethics approval, and activate the site. This stage runs in parallel with the IND review.
Stage 5: Single Ascending Dose (SAD)
Give single doses to successive cohorts at increasing dose levels, with a safety review before each escalation.
Stage 6: Multiple Ascending Dose (MAD)
Give repeated doses to successive cohorts to characterize steady-state exposure, accumulation and tolerability. MAD often starts once SAD exposure covers the planned MAD exposure.
Stage 7: Safety Monitoring and Reporting
Monitor, assess and report safety data from the first dose until the last subject completes follow-up.
Stage 8: Bioanalysis, Database Lock and Clinical Study Report
Analyze samples, clean and lock the data, and report the results.
Stage 9: End of Phase 1 and Transition to Phase 2
Integrate the Phase 1 data, choose the Phase 2 dose range and prepare the next protocol.
Find the gaps in your IND package before you file
Score your program against the IND requirements in 21 CFR 312 and ICH with the free IND readiness assessment from Cambrian Life Sciences.
Get ranked gaps with remediation notes and an ordered plan for the next 12 months. Book a demo to see your own milestones, sites and budget in Cambrian.
This planner shows typical ranges and common industry practice. Your timelines depend on the molecule, the indication, your sites and regulator feedback, so confirm the requirements for your program with your regulatory and clinical team.