Safety, Tolerability, Pharmacokinetics of AEF0217Phase 1AEF0217-101NCT05170737

AEF0217 First-in-Human Phase I Study in 3 Parts (Single and Multiple Ascending Doses, and Food Effect) in Healthy Subjects.

A Phase 1 study testing AEF0217 in people with Safety, Tolerability, Pharmacokinetics of AEF0217, run by Aelis Farma at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Safety, Tolerability, Pharmacokinetics of AEF0217
What is being tested?: AEF0217
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 68 participants
Where: 1 siteSpain
Study dates: 1 Oct 2021to 28 Jun 2022
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy male subjects: As the effect of the study drug on sperm is still unknown, male subjects should refrain from donating sperm or plan a pregnancy with their partner throughout the study and until 90 days after the trial and must report immediately to the study doctor if its partner becomes pregnant during the trial and during 90 days after the trial. The male subject will have to use double-barrier contraceptive methods: male condoms and spermicide.
Healthy female subjects of non-child-bearing potential: females may be accepted if they are documented to be surgically sterile i.e., hysterectomy, tubal ligation or post-menopausal with a negative pregnancy test (Not applicable for FIH-FE part III as it includes male only)
Age ≥ 18 and ≤ 55 years.
Weight ≥ 50 kg and ≤ 100 kg.
Body mass index (BMI) ≥ 18 and ≤ 30.
Negative serum pregnancy test (women only)

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Non-smoking.
No history of or ongoing clinically relevant diseases or conditions.
No clinically relevant findings in physical examination, vital signs (blood pressure, heart rate and body temperature), ECG and safety laboratory parameters that should be within normal ranges or considered as non-clinically relevant by the investigator.
Negative covid19 PCR test within 72h before admission
Able/willing to accept restrictions regarding diet, physical exercise, and consumption of alcohol and/or xanthine containing items when out of CRU.
Able to read Spanish and adhere to study requirements.
Not under any administrative or legal supervision.
Signed informed consent prior to any study-mandated procedure.

Who cannot join

Women of child-bearing potential
Life-time substance use disorders (SUD) according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5).
Recreational use of drugs of abuse within the last month prior to study drug administration.
Positive blood or urine test for drugs of abuse or alcohol breath test prior to study drug administration.
Life-time history of bipolar disorders, psychosis or suicidal attempts assessed by the Dual Diagnosis Screening Instrument (DDSI).
History of anxiety or depression not completely recovered within 12 months prior to study drug administration, as assessed by the DDSI.

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Lifetime history of deliberate self-harm due to suicidal ideation or suicidal ideation prior to study drug administration, as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS).
Clinically relevant cognitive impairment preventing the administration of the psychometric tests
Any other clinically relevant disease or condition that in the judgment of the investigator might interfere with the subject's ability to comply with study procedures or requirements and/or bias the interpretation of the study results and/or jeopardize the subject's safety.
Ongoing gastrointestinal diseases or history of gastrointestinal surgery affecting absorption
Subjects with a clinically significant disease within one month prior to study drug administration.
Any clinically relevant findings in physical examination, vital signs, ECG and safety laboratory parameters.
Positive hepatitis or HIV test.
Positive Covid19 PCR test within 72h before admission (Day -1) to the research facility
Have abnormal screening values for the steroid hormones: cortisol, testosterone, estradiol and progesterone relative to their reproductive status.
Known hypersensitivity to any drug (in particular steroids) or drug excipients.
Use of drugs known to induce or inhibit hepatic drug metabolism within one month prior to study administration or during the study and use of citrus juice during the study.
Any prescription or over-the-counter (OTC) product including herbal, homeopathic, vitamins, minerals and nutritional supplements and in particular any parenteral or topical product containing steroids, within 2 weeks (or more considering the elimination half-life of the product) prior to study drug administration
Donation of blood or plasma within one month prior to study drug administration or transfusion of blood or plasma for medical/surgical reasons or intention to donate blood or plasma within one month after study drug administration.
History of inadequate venous access and/or experience of difficulty donating blood.
Not able/not willing to accept restrictions regarding diet, physical exercise, and consumption of alcohol and/or xanthine containing items when out of CRU.
Subject included in a clinical study within 3 months prior to study drug administration.
Subject already included in other parts of this study

Trial locations and contacts

1 site in 1 country.

Spain1 site

Hospital del Mar Medical Research Institute (IMIM) Neurosciences Research Program
Barcelona, 08003

Other trials in Spain

About this study

Official title: A First-In-Human Phase I Study in 3 Parts: Randomized, Double-blind, Placebocontrolled, Sequential Group Investigation of the Safety, Tolerability, Pharmacokinetics of AEF0217 After Oral, Single and Multiple Ascending Doses, and an Open Label, Cross-over Investigation of the Effect of Food on the Bioavailability of AEF0217 in Healthy Volunteers.

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.

Conditions: Safety, Tolerability, Pharmacokinetics of AEF0217
Being tested: AEF0217, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AEF0217Drug
Also called 3ß-benzyloxy-17α-methyl-pregn-5-en-20-one
PART I: A total of 32 healthy male and female subjects will be randomized into four consecutive single ascending dose cohorts of 8 subjects. The study will have 4 different doses of AEF0217 (0.2, 0.6, 2 \& 6 mg) and 1 dose of matching placebo. A given subject can be randomized only in one dose level cohort.
PART II: A total of 24 healthy subjects will be randomized in three consecutive multiple ascending dose cohorts of 8 subjects. The study will have 3 different doses of AEF0217 (0.6, 2 \& 6 mg) and 1 dose of matching placebo. Doses could be modified following the results of FIH-SAD. A given subject can be randomized only in one dose level cohort.
PART III: A total of 12 healthy male subjects will be randomly assigned to one of two sequences in the crossover study part. All subjects will receive the same dose of AEF0117 which will be determined following the results of the FIH-SAD.
PlaceboDrug
PART I: A total of 32 healthy male and female subjects will be randomized into four consecutive single ascending dose cohorts of 8 subjects. The study will have 4 different doses of AEF0217 (0.2, 0.6, 2 \& 6 mg) and 1 dose of matching placebo. A given subject can be randomized only in one dose level cohort.
PART II: A total of 24 healthy subjects will be randomized in three consecutive multiple ascending dose cohorts of 8 subjects. The study will have 3 different doses of AEF0217 (0.6, 2 \& 6 mg) and 1 dose of matching placebo. Doses could be modified following the results of FIH-SAD. A given subject can be randomized only in one dose level cohort.

Study groups in NCT05170737
Study group	Role	What they receive
PART I: SINGLE ASCENDING DOSE (FIH-SAD)	Experimental	Prospective, monocenter, double-blind, randomized, placebo-controlled, subsequent-group, Phase I investigation to assess the safety, tolerability and pharmacokinetics of AEF0217 administered orally in single ascending doses. Receives: Drug: AEF0217; Drug: Placebo
PART II: MULTIPLE ASCENDING DOSES (FIH-MAD)	Experimental	Prospective, monocenter, double-blind, randomized, placebo-controlled, subsequent-groups, Phase I investigation to assess the safety, tolerability and pharmacokinetics of AEF0217 administered orally in multiple ascending doses. Receives: Drug: AEF0217; Drug: Placebo
PART III: FOOD EFFECT (FIH-FE)	Experimental	Prospective, open-label single dose, two-condition (fed versus fasting), two sequences, crossover phase I investigation to assess the effects of food on the bioavailability of AEF0217. Receives: Drug: AEF0217

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of treatment-emergent AEs and SAEs as assessed by vital signs
Evaluation by grade intensity and by evaluating changes from the baseline in vital signs Treatment-emergent potentially clinically significant abnormalities (PSCAs) in vital signs, ECG and safety laboratory parameters from Day 1 to EOS.
Psychopathological tests: Profile of Mood States 2nd edition questionnaire (POMS-2), Hospital Anxiety and Depression rating scale (HADS), Addiction Research Center Inventory 49 checklist (ARCI-49), Columbia-Suicide Severity Rating Scale (C-SSRS)
Measured: 168 hours from dosing
Incidence of treatment-emergent AEs and SAEs as assessed by ECGs
Evaluation by grade intensity and by evaluating changes from the baseline in ECGs
Measured: 168 hours from dosing
Incidence of treatment-emergent AEs and SAEs as assessed by clinical laboratory values
Evaluation by grade intensity and by evaluating changes from the baseline in clinical laboratory values from blood and urine samples.
Measured: 168 hours from dosing
Incidence of treatment-emergent AEs and SAEs as assessed by psychometric tests
Evaluation by grade intensity and by evaluating changes from the baseline in psychometric tests (Bond and Lader VAS, ARCI, POMS) and C-SSRS test.
Measured: 36 hours from dosing

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 202128 Jun 2022

First posted28 Dec 2021
Study start1 Oct 2021
Primary completion28 Jun 2022
Study completion28 Jun 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Safety, Tolerability, Pharmacokinetics of AEF0217Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 68 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05170737
Sponsor's protocol ID: AEF0217-101
Other IDs: 2020-005201-99
Acronym: AEF0217-101
Status last verified: Jan 2024
First submitted: 7 Dec 2021
Last updated: 1 Feb 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A First-In-Human Phase I Study in 3 Parts: Randomized, Double-blind, Placebocontrolled, Sequential Group Investigation of the Safety, Tolerability, Pharmacokinetics of AEF0217 After Oral, Single and Multiple Ascending Doses, and an Open Label, Cross-over Investigation of the Effect of Food on the Bioavailability of AEF0217 in Healthy Volunteers.
ClinicalTrials.gov ID: NCT05170737
Acronym / sponsor ID: AEF0217-101 / AEF0217-101
Conditions: Safety, Tolerability, Pharmacokinetics of AEF0217
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 68 participants (actual)
Lead sponsor: Aelis FarmaIndustry (pharma, biotech, devices)
Collaborators: European Commission
Study start: 1 Oct 2021 (actual)
Primary completion: 28 Jun 2022 (actual)
Study completion: 28 Jun 2022 (actual)
First posted: 28 Dec 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
PART I: SINGLE ASCENDING DOSE (FIH-SAD)	Experimental	Drug: AEF0217, Drug: PlaceboProspective, monocenter, double-blind, randomized, placebo-controlled, subsequent-group, Phase I investigation to assess the safety, tolerability and pharmacokinetics of AEF0217 administered orally in single ascending doses.
PART II: MULTIPLE ASCENDING DOSES (FIH-MAD)	Experimental	Drug: AEF0217, Drug: PlaceboProspective, monocenter, double-blind, randomized, placebo-controlled, subsequent-groups, Phase I investigation to assess the safety, tolerability and pharmacokinetics of AEF0217 administered orally in multiple ascending doses.
PART III: FOOD EFFECT (FIH-FE)	Experimental	Drug: AEF0217Prospective, open-label single dose, two-condition (fed versus fasting), two sequences, crossover phase I investigation to assess the effects of food on the bioavailability of AEF0217.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (14 listed)

Healthy male subjects: As the effect of the study drug on sperm is still unknown, male subjects should refrain from donating sperm or plan a pregnancy with their partner throughout the study and until 90 days after the trial and must report immediately to the study doctor if its partner becomes pregnant during the trial and during 90 days after the trial. The male subject will have to use double-barrier contraceptive methods: male condoms and spermicide.
Healthy female subjects of non-child-bearing potential: females may be accepted if they are documented to be surgically sterile i.e., hysterectomy, tubal ligation or post-menopausal with a negative pregnancy test (Not applicable for FIH-FE part III as it includes male only)
Age ≥ 18 and ≤ 55 years.
Weight ≥ 50 kg and ≤ 100 kg.
Body mass index (BMI) ≥ 18 and ≤ 30.

Key exclusion criteria (23 listed)

Women of child-bearing potential
Life-time substance use disorders (SUD) according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5).
Recreational use of drugs of abuse within the last month prior to study drug administration.
Positive blood or urine test for drugs of abuse or alcohol breath test prior to study drug administration.
Life-time history of bipolar disorders, psychosis or suicidal attempts assessed by the Dual Diagnosis Screening Instrument (DDSI).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AEF0217Also: 3ß-benzyloxy-17α-methyl-pregn-5-en-20-onePART I: A total of 32 healthy male and female subjects will be randomized into four consecutive single ascending dose cohorts of 8 subjects. The study will have 4 different doses of AEF0217 (0.2, 0.6, 2 \& 6 mg) and 1 dose of matching placebo. A given subject can be randomized only in one dose level cohort. PART II: A total of 24 healthy subjects will be randomized in three consecutive multiple ascending dose cohorts of 8 subjects. The study will have 3 different doses of AEF0217 (0.6, 2 \& 6 mg) and 1 dose of matching placebo. Doses could be modified following the results of FIH-SAD. A given subject can be randomized only in one dose level cohort. PART III: A total of 12 healthy male subjects will be randomly assigned to one of two sequences in the crossover study part. All subjects will receive the same dose of AEF0117 which will be determined following the results of the FIH-SAD.	Drug	PART I: SINGLE ASCENDING DOSE (FIH-SAD), PART II: MULTIPLE ASCENDING DOSES (FIH-MAD), PART III: FOOD EFFECT (FIH-FE)
PlaceboPART I: A total of 32 healthy male and female subjects will be randomized into four consecutive single ascending dose cohorts of 8 subjects. The study will have 4 different doses of AEF0217 (0.2, 0.6, 2 \& 6 mg) and 1 dose of matching placebo. A given subject can be randomized only in one dose level cohort. PART II: A total of 24 healthy subjects will be randomized in three consecutive multiple ascending dose cohorts of 8 subjects. The study will have 3 different doses of AEF0217 (0.6, 2 \& 6 mg) and 1 dose of matching placebo. Doses could be modified following the results of FIH-SAD. A given subject can be randomized only in one dose level cohort.	Drug	PART I: SINGLE ASCENDING DOSE (FIH-SAD), PART II: MULTIPLE ASCENDING DOSES (FIH-MAD)

Primary outcome

Incidence of treatment-emergent AEs and SAEs as assessed by vital signs
Time frame: 168 hours from dosing
Evaluation by grade intensity and by evaluating changes from the baseline in vital signs Treatment-emergent potentially clinically significant abnormalities (PSCAs) in vital signs, ECG and safety laboratory parameters from Day 1 to EOS. Psychopathological tests: Profile of Mood States 2nd edition questionnaire (POMS-2), Hospital Anxiety and Depression rating scale (HADS), Addiction Research Center Inventory 49 checklist (ARCI-49), Columbia-Suicide Severity Rating Scale (C-SSRS)
Incidence of treatment-emergent AEs and SAEs as assessed by ECGs
Time frame: 168 hours from dosing
Evaluation by grade intensity and by evaluating changes from the baseline in ECGs
Incidence of treatment-emergent AEs and SAEs as assessed by clinical laboratory values
Time frame: 168 hours from dosing
Evaluation by grade intensity and by evaluating changes from the baseline in clinical laboratory values from blood and urine samples.
Incidence of treatment-emergent AEs and SAEs as assessed by psychometric tests
Time frame: 36 hours from dosing
Evaluation by grade intensity and by evaluating changes from the baseline in psychometric tests (Bond and Lader VAS, ARCI, POMS) and C-SSRS test.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Rafael de la Torre Fornel, PhD principal investigator

IMIM

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AEF0217 in people with Safety, Tolerability, Pharmacokinetics of AEF0217, run by Aelis Farma at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of treatment-emergent AEs and SAEs as assessed by vital signs (time frame: 168 hours from dosing). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05170737.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2024.