Healthy VolunteersPhase 1NCT05169671
Safety, Tolerability, and Pharmacokinetics Study of ATH-1020
A Phase 1 study testing ATH-1020 in people with Healthy Volunteers, run by LeonaBio at 1 site in United States.
Trial summary
This Phase 1 randomized, placebo-controlled, double-blinded, first-in-human study will evaluate safety, tolerability, and pharmacokinetics of single and multiple ascending doses of ATH-1020 in healthy young and elderly subjects. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- ATH-1020
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Mar 2022to 9 Sep 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All Subjects
- Body mass index (BMI) of ≥ 18.0 and ≤ 32.0 kg/m2 at Screening, with minimum weight of 60 kg.
- Subjects in generally good health per the investigator's discretion.
- Male subjects and their partners must be willing to comply with the contraceptive requirements of the study.
- Subjects must have adequate venous access.
- Part A (SAD)
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- Male subjects aged 18 to 50 years at the time of signing the informed consent.
- Part B (MAD)
- Male subjects aged 18 to 50 years (Cohorts B1, B2, B3, and B5); male and post-menopausal female subjects aged 65 to 85 years (Cohort B4) at the time of signing the informed consent.
Who cannot join
- History of significant drug allergies (including to any excipients) or of anaphylactic reaction.
- Any condition per the investigator's discretion, which while not requiring chronic medication use, is likely to require intermittent/acute therapeutic intervention.
- Any history of seizures or loss of consciousness for an unknown reason.
- History of or positive results of serology screening for hepatitis B, hepatitis C or human immunodeficiency virus (HIV).
- Abnormal liver tests
- Impaired renal function.
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- History of having taken another investigational drug within 30 days prior to Admission (Day -1).
- Major surgery within 90 days prior to Admission (Day -1) or anticipated surgery during the study.
- Part A (SAD)
- Female subjects are not permitted.
- Any medical condition that requires chronic medication use.
- Part B (MAD)
- A history of intermittent benzodiazepine (short-acting only) or other treatments for insomnia and anxiety are allowed, provided that the subject is able to abstain from their use during the Screening period, and from Admission until discharge from the study.
- Reported changes in cognition and reported history of declines in everyday life in the last year.
- Part B (MAD) CSF Sampling (Cohort B5)
- Subject history of or current contraindication to lumbar puncture/spinal catheterization.
- Clinically significant abnormalities in coagulation parameters.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Placebo-Controlled, Double-Blinded, First-in-Human, Adaptive Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses (Part A) and Multiple Ascending Doses (Part B) of Orally Administered ATH-1020 in Healthy Young and Elderly Subjects
This Phase 1 randomized, placebo-controlled, double-blinded, first-in-human study will evaluate safety, tolerability, and pharmacokinetics of single and multiple ascending doses of ATH-1020 in healthy young and elderly subjects.
Read the detailed description
This is a Phase 1 first-in-human, 2-part adaptive study. Both Part A and Part B will be performed in a randomized, placebo-controlled, and double-blind manner.
Part A - Single Ascending Dose (SAD) Part A will be a SAD study investigating multiple dose levels of ATH 1020.
Part B - Multiple Ascending Dose (MAD) Part B will be a multiple ascending dose (MAD) study investigating multiple dose levels of ATH-1020.
Subjects in Cohort B5 (4 subjects) will additionally undergo CSF sampling pre-dose on Day 4 and up to 3 post dose timepoints to evaluate ATH-1020 blood-brain-barrier penetration
- Conditions
- Healthy Volunteers
- Being tested
- ATH-1020, Placebo
- Keywords
- Pharmacokinetics, HGF/MET
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATH-1020Drug
ATH-1020 in oral capsule form
PlaceboDrug
Placebo in oral capsule form
| Study group | Role | What they receive |
|---|---|---|
| ATH-1020 | Experimental | ATH-1020 in oral form. Participants in the single ascending dose cohort (Cohort A) will receive a single dose of ATH-1020. Participants in the multiple ascending dose cohort (Cohort B) will receive up to nine doses of ATH-1020 (up to 4 for cohort B5). Receives: Drug: ATH-1020 |
| Placebo | Placebo comparator | Placebo in oral form. Participants in the single ascending dose cohort (Cohort A) will receive a single dose of Placebo. Participants in the multiple ascending dose cohort (Cohort B) will receive up to nine doses of placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Safety and tolerability of single or multiple ascending doses of ATH-1020 as measured by vital signs and clinical laboratory measurements.
Measured: Up to 12 days post initial dosing (Part A); Up to 19 days post initial dosing (Part B)
Secondary outcomes (6)
Maximum observed plasma concentration (Cmax)
Cmax will be determined from all collected plasma samples from baseline through up to 48 hours post-dose.
Measured: Cmax will be determined from all collected plasma samples from baseline through up to 48 hours post-dose.
Time to maximum observed plasma concentration (Tmax)
Tmax will be determined from all collected plasma samples from baseline through up to 48 hours post-dose.
Measured: Samples collected pre-dose and at predetermined timepoints within 48 hours post-dose.
Plasma concentration at the end of the dosing interval (Ctrough)
Ctrough will be determined from the last plasma sample prior to the following dose (cohort B only).
Measured: Samples collected pre-dose and at predetermined timepoints within 24 hours post-dose.
Area under the plasma concentration time curve (AUC)
AUC will be determined from all collected plasma samples from baseline through up to 48 hours post-dose.
Measured: Samples collected pre-dose and at predetermined timepoints within 48 hours post-dose.
Half-life (t1/2)
t1/2 will be determined from all collected plasma samples from baseline through up to 48 hours post-dose.
Measured: Samples collected pre-dose and at predetermined timepoints within 48 hours post-dose.
Amount of IMP excreted unchanged in the urine (Ae)
Ae will be determined from all collected urine samples from baseline through up to 24 hours post-dose (cohort B1-4 only).
Measured: Samples collected pre-dose on Day 1 and predetermined timepoints on Day 1, 9, and 10, within 24 hours post-dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2021
- Study start30 Mar 2022
- Primary completion9 Sep 2022
- Study completion9 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- LeonaBio
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biotrial Inc., Alturas Analytics, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05169671
- Sponsor's protocol ID
- ATH-1020-0101
- Status last verified
- Apr 2024
- First submitted
- 6 Dec 2021
- Last updated
- 8 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-Controlled, Double-Blinded, First-in-Human, Adaptive Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses (Part A) and Multiple Ascending Doses (Part B) of Orally Administered ATH-1020 in Healthy Young and Elderly Subjects
- ClinicalTrials.gov ID
- NCT05169671
- Acronym / sponsor ID
- ATH-1020-0101
- Conditions
- Healthy Volunteers
- Keywords
- Pharmacokinetics, HGF/MET
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- LeonaBioIndustry (pharma, biotech, devices)
- Collaborators
- Biotrial Inc., Alturas Analytics, Inc.
- Study start
- 30 Mar 2022 (actual)
- Primary completion
- 9 Sep 2022 (actual)
- Study completion
- 9 Sep 2022 (actual)
- First posted
- 27 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.
This Phase 1 randomized, placebo-controlled, double-blinded, first-in-human study will evaluate safety, tolerability, and pharmacokinetics of single and multiple ascending doses of ATH-1020 in healthy young and elderly subjects.
Detailed description
This is a Phase 1 first-in-human, 2-part adaptive study. Both Part A and Part B will be performed in a randomized, placebo-controlled, and double-blind manner.
Part A - Single Ascending Dose (SAD) Part A will be a SAD study investigating multiple dose levels of ATH 1020.
Part B - Multiple Ascending Dose (MAD) Part B will be a multiple ascending dose (MAD) study investigating multiple dose levels of ATH-1020.
Subjects in Cohort B5 (4 subjects) will additionally undergo CSF sampling pre-dose on Day 4 and up to 3 post dose timepoints to evaluate ATH-1020 blood-brain-barrier penetration
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ATH-1020 | Experimental | Drug: ATH-1020ATH-1020 in oral form. Participants in the single ascending dose cohort (Cohort A) will receive a single dose of ATH-1020. Participants in the multiple ascending dose cohort (Cohort B) will receive up to nine doses of ATH-1020 (up to 4 for cohort B5). |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo in oral form. Participants in the single ascending dose cohort (Cohort A) will receive a single dose of Placebo. Participants in the multiple ascending dose cohort (Cohort B) will receive up to nine doses of placebo. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- All Subjects
- Body mass index (BMI) of ≥ 18.0 and ≤ 32.0 kg/m2 at Screening, with minimum weight of 60 kg.
- Subjects in generally good health per the investigator's discretion.
- Male subjects and their partners must be willing to comply with the contraceptive requirements of the study.
- Subjects must have adequate venous access.
Key exclusion criteria (17 listed)
- History of significant drug allergies (including to any excipients) or of anaphylactic reaction.
- Any condition per the investigator's discretion, which while not requiring chronic medication use, is likely to require intermittent/acute therapeutic intervention.
- Any history of seizures or loss of consciousness for an unknown reason.
- History of or positive results of serology screening for hepatitis B, hepatitis C or human immunodeficiency virus (HIV).
- Abnormal liver tests
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 |
|---|---|---|
| ATH-1020ATH-1020 in oral capsule form | Drug | ATH-1020 |
| PlaceboPlacebo in oral capsule form | Drug | Placebo |
Primary outcome
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Time frame: Up to 12 days post initial dosing (Part A); Up to 19 days post initial dosing (Part B)
Safety and tolerability of single or multiple ascending doses of ATH-1020 as measured by vital signs and clinical laboratory measurements.
6 secondary outcomes
Maximum observed plasma concentration (Cmax)
Time frame: Cmax will be determined from all collected plasma samples from baseline through up to 48 hours post-dose.
Time to maximum observed plasma concentration (Tmax)
Time frame: Samples collected pre-dose and at predetermined timepoints within 48 hours post-dose.
Plasma concentration at the end of the dosing interval (Ctrough)
Time frame: Samples collected pre-dose and at predetermined timepoints within 24 hours post-dose.
Area under the plasma concentration time curve (AUC)
Time frame: Samples collected pre-dose and at predetermined timepoints within 48 hours post-dose.
Half-life (t1/2)
Time frame: Samples collected pre-dose and at predetermined timepoints within 48 hours post-dose.
Amount of IMP excreted unchanged in the urine (Ae)
Time frame: Samples collected pre-dose on Day 1 and predetermined timepoints on Day 1, 9, and 10, within 24 hours post-dose.
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 8 Apr 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 ATH-1020 in people with Healthy Volunteers, run by LeonaBio at 1 site in United States.
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 9 inclusion and 17 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 8 Apr 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 United States. 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. Some participants in this study may receive a placebo. 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 Adverse Events (Safety and Tolerability) (time frame: Up to 12 days post initial dosing (Part A); Up to 19 days post initial dosing (Part B)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Apr 2024; AzTrials last refreshed its copy on 7 Nov 2026.