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NCT05170737: AEF0217-101
AEF0217 First-in-Human Phase I Study in 3 Parts (Single and Multiple Ascending Doses, and Food Effect) in Healthy Subjects.
Phase 1 trial testing AEF0217 in Safety, Tolerability, Pharmacokinetics of AEF0217 in 68 participants. Completed in 28 June 2022.
28 June 2022
Quick facts
| Lead sponsor | Aelis Farma |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | sequential |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 68 |
| Start date | 1 October 2021 |
| Primary completion | 28 June 2022 |
| Estimated completion | 28 June 2022 |
| Sites | 1 location across Spain |
Drugs / interventions tested
- AEF0217 — full drug profile →
- Placebo
Conditions studied
- Safety, Tolerability, Pharmacokinetics of AEF0217 — all drugs for Safety, Tolerability, Pharmacokinetics of AEF0217 →
Sponsor
Aelis Farma — full company profile →
Who can join
Adults 18 to 55, any sex, with Safety, Tolerability, Pharmacokinetics of AEF0217. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This trial is divided in 3 parts: FIH-SAD (Single Ascending Doses), FIH-MAD (Multiple Ascending Doses) and FIH-FE (Food effects). FIH-SAD will start first. The start of FIH-MAD will await the results of at least three cohorts from the FIHSAD study before initiated. The starting dose of the FIH-MAD will have been shown to be well tolerated and one dose level lower than the highest dose for which safety, tolerability and pharmacokinetic (PK) data are available. FIH-FE will be the last to start after the completion of FIH-SAD and conducted in parallel with parts of FIH-MAD.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05170737
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of AEF0217
Trials testing the same drug.
- NCT05748405 — Phase 1/2 Trial of AEF0217 in Participants With Down Syndrome · Phase 1, PHASE2 · completed
Other Aelis Farma trials
Trials by the same sponsor.
- NCT07334912 — AEF0217 in Participants With Down Syndrome · Phase 2 · recruiting
- NCT05451017 — The Effect of Food on the Oral Bioavailability of AEF0117 in Healthy Volunteers · Phase 1 · terminated
- NCT05554926 — Study of [4-14C] AEF0117 Following a Single Oral Dose in Healthy Male Subjects · Phase 1 · completed
- NCT05748405 — Phase 1/2 Trial of AEF0217 in Participants With Down Syndrome · Phase 1, PHASE2 · completed
- NCT05322941 — Effect of AEF0117 on Treatment-seeking Patients With Cannabis Use Disorder (CUD) · Phase 2 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05170737 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Aelis Farma
- Last refreshed: 1 February 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05170737.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing