7 completed, 2 unknown, 1 enrolling by invitation, 1 recruiting. 7 Phase 1, 4 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 7 | Completed 5, Terminated 1, Withdrawn 1 |
| Phase 2 | 4 | Completed 3, Recruiting 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Qualitative Effects of AEF0217 in Down Syndrome People Down Syndrome (Trisomy 21) | Enrolling by invitation | Aelis Farma | 28 | 2026-03-01 | 2026-04-08 | |
| AEF0217 in Participants With Down Syndrome AEF0217 100 µg, AEF0217 300 µg, Placebo - Down Syndrome (Trisomy 21) | Phase 2 | Recruiting | Aelis Farma | 188 | 2025-12-22 | 2026-04-08 |
| Drug-Drug Interaction Between THC and AEF0117 3ß-(4-methoxybenzyloxy)pregn-5-en-20-one, Placebo - Cannabis Abuse | Phase 1 | Withdrawn | Aelis Farma | 2025-12-01 | 2026-02-27 | |
| The Effect of Food on the Oral Bioavailability of AEF0117 in Healthy Volunteers 3ß-(4-methoxybenzyloxy)pregn-5-en-20-one in fed condition, 3ß-(4-methoxybenzyloxy)pregn-5-en-20-one in fasting condition - Marijuana Abuse | Phase 1 | Terminated | Aelis Farma | 22 | 2023-01-04 | 2026-01-22 |
| Study of [4-14C] AEF0117 Following a Single Oral Dose in Healthy Male Subjects AEF0117 - Marijuana Abuse | Phase 1 | Completed | Aelis Farma | 8 | 2022-12-16 | 2023-04-07 |
| Phase 1/2 Trial of AEF0217 in Participants With Down Syndrome Placebo, AEF0217 - Down Syndrome | Phase 1 / Phase 2 | Completed | Aelis Farma | 40 | 2022-12-15 | 2024-10-10 |
| Effect of AEF0117 on Treatment-seeking Patients With Cannabis Use Disorder (CUD) AEF0117, Placebo oral capsule - Marijuana Abuse | Phase 2 | Completed | Aelis Farma | 333 | 2022-05-06 | 2024-07-30 |
| AEF0217 First-in-Human Phase I Study in 3 Parts (Single and Multiple Ascending Doses, and Food Effect) in Healthy Subjects. AEF0217, Placebo - Safety, Tolerability, Pharmacokinetics of AEF0217 | Phase 1 | Completed | Aelis Farma | 68 | 2021-10-01 | 2024-02-01 |
| Assessment of Neural Oscillations in Adult Subjects With Down Syndrome and Typically Developing Subjects in Resting State and While Conducting Cognitive Tasks Electroencephalography - Down Syndrome | Unknown | Parc de Salut Mar | 48 | 2021-01-11 | 2021-03-10 | |
| Clinical Validation of the Bordeaux Maze Test Down Syndrome, Healthy | Unknown | Parc de Salut Mar | 50 | 2019-04-05 | 2020-01-27 | |
| Effect of AEF0117 on Subjective Effects of Cannabis in CUD Subjects AEF0117, Placebo oral capsule - Marijuana Abuse | Phase 2 | Completed | Aelis Farma | 29 | 2018-10-23 | 2021-06-02 |
| Multiple Ascending Dose to Study the Safety, Tolerability, PK and PD Effects of AEF0117 AEF0117 oral capsule, Placebo oral capsule - Healthy Volunteers | Phase 1 | Completed | Aelis Farma | 24 | 2018-01-08 | 2018-06-19 |
| Single Ascending Dose to Study the Safety, Tolerability, PK and PD Effects of AEF0117 AEF0117, Placebo - Healthy Volunteers | Phase 1 | Completed | Aelis Farma | 40 | 2017-04-06 | 2018-03-13 |
Down Syndrome (5) · Marijuana Abuse (5) · Cognitive Dysfunction (1)
Spain (6) · United States (6) · France (1) · Italy (1)
Margaret Haney, PhD (2) · Michael Dobrow, MD (2) · Frances Levin, MD (1) · Haig Goenjian, MD (1) · Irene Mirkin, MD (1) · Jennifer Potter, MD (1) · Jennifer Wisdom, MD (1) · Kevin Gray, MD (1) · Larissa Mooney, MD (1) · Margareth Haney, PhD (1) · Matt Evans, MD (1) · Olga Lapeyra, MD (1) · Paul Thielking, MD (1) · Pier Vincenzo Piazza, MD, PhD (1)
R01DA038875 (3), U01DA053832 (2), 2025 (1)