Healthy VolunteersPhase 1NCT06432647
A SAD and MAD Study of the Safety, Tolerability, and Pharmacokinetics of ATH-1105
A Phase 1 study testing ATH-1105 in people with Healthy Volunteers, run by LeonaBio at 1 site in United States.
Trial summary
The goal of this Phase 1 interventional study is to assess the safety, tolerability and pharmacokinetics of ATH-1105 in healthy male and female participants. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- ATH-1105
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Apr 2024to 25 Nov 2024
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body mass index between 18.0 and 32.0 kg/m2 inclusive.
- In good health, determined by no clinically significant findings from medical history, 12-lead ECG, vital signs measurements, and clinical laboratory evaluations at screening and check-in or predose on Day 1
- Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception
- Able to comprehend and willing to sign an ICF and to abide by the study restrictions.
Who cannot join
- Medical Conditions:
- Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder
- History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance
- History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs
- Any of the following:
- QTcF >450 ms in males or >470 ms in females
Show all 19Show fewer
- QRS duration >110 ms
- PR interval >220 ms
- Findings which would make QTc measurements difficult or QTc data uninterpretable.
- History of additional risk factors for torsades de pointes
- Confirmed systolic blood pressure >140 or <90 mmHg, diastolic blood pressure >90 or <50 mmHg, and pulse rate >100 or <40 beats per minute.
- Positive hepatitis panel and/or positive human immunodeficiency virus test
- Part B only: Current psychiatric disorder, suicidal ideation in the previous 2 years (as assessed by the Columbia-Suicide Severity Rating Scale [C-SSRS]), or a lifetime suicide attempt.
- Prior/concomitant therapy:
- Administration of any vaccine in the 30 days prior to dosing.
- Use or intend to use any medications/products known to alter drug absorption, metabolism, or elimination processes
- Use or intend to use any prescription medications/products other than hormone replacement therapy, oral, implantable, transdermal, injectable, or intrauterine contraceptives within 14 days prior to dosing
- Use or intend to use slow-release medications/products considered to still be active within 14 days prior to check-in
- Use or intend to use any nonprescription medications/products including vitamins, minerals, and phytotherapeutic/herbal/plant-derived preparations within 7 days prior to check-in
Trial locations and contacts
1 site in 1 country.
United States1 site
Fortrea Clinical Research Unit Inc.
Dallas, Texas, 75247
About this study
Official title: ATH-1105 A Phase 1, Double-Blind, Placebo-Controlled, Single-and-Multiple-Oral-Dose, Safety, Tolerability, and Pharmacokinetic Study in Healthy Male and Female Subjects
The goal of this Phase 1 interventional study is to assess the safety, tolerability and pharmacokinetics of ATH-1105 in healthy male and female participants.
Read the detailed description
The study is a Phase 1, First-In-Human study consisting of two parts (A and B). Part A will comprise a single-dose, double-blind, placebo-controlled, sequential-group design. Part B will comprise a multiple-dose, placebo-controlled, sequential-group design.
- Conditions
- Healthy Volunteers
- Being tested
- ATH-1105, Placebo
- Keywords
- ATH-1105
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATH-1105Drug
ATH-1105 in oral form. Participants will be administered ATH-1105 once in Part A and once daily for 10 days in Part B.
PlaceboDrug
Placebo in oral form. Participants will be administered Placebo once in Part A and once daily for 10 days in Part B.
| Study group | Role | What they receive |
|---|---|---|
| ATH-1105 | Experimental | Part A: ATH-1105 administered once as an oral solution.
Part B: ATH-1105 administered once daily as an oral solution for 10 days. Receives: Drug: ATH-1105 |
| Placebo | Placebo comparator | Part A: Placebo administered once as an oral solution
Part B: Placebo administered once daily as an oral solution 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 of single or multiple ascending doses of ATH-1105 as measured by incidence of AEs, determined by clinical laboratory tests, physical examinations, vital signs measurements, and 12-lead ECG
Measured: Part A: Up to 7 days post-dose, Part B: Up to 7 days post final dose on day 10
Severity of Treatment-Emergent Adverse Events
Treatment-emergent adverse events will be graded on a 1 through 5 scale, based on severity as determined by the principal investigator.
Measured: Part A: Up to 7 days post-dose, Part B: Up to 7 days post final dose on day 10
Secondary outcomes (8)
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: Part A: Up to 48 hours post-dose, Part B: Up to 48 hours post final dose on Day 10
Maximum observed plasma concentration (Cmax)
Cmax will be determined from all collected plasma samples from baseline through up to 48 hours post-dose.
Measured: Part A: Up to 48 hours post-dose, Part B: Up to 48 hours post final dose on Day 10
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: Part A: Up to 48 hours post-dose, Part B: Up to 48 hours post final dose on Day 10
Half-life (t1/2)
t1/2 will be determined from all collected plasma samples from baseline through up to 48 hours post-dose.
Measured: Part A: Up to 48 hours post-dose, Part B: Up to 48 hours post final dose on Day 10
Amount of IMP excreted unchanged in the urine (Ae)
Amount of IMP excreted unchanged in the urine will be determined from all collected urine samples from baseline through up to 48 hours post-dose
Measured: Part A: Up to 48 hours post-dose, Part B: Up to 48 hours post final dose on Day 10
IMP Concentration in Cerebrospinal Fluid
Amount of IMP in the urine will be determined from all collected CSF samples from baseline through up to 48 hours post-dose
Measured: Will occur at calculated maximum plasma concentration.
Accumulation Ratio (AUC) of IMP in Urine
Accumulation Ratio in urine will be determined from all collected urine samples from baseline through up to 48 hours post-dose
Measured: Part A: Up to 48 hours post-dose, Part B: Up to 48 hours post final dose on Day 10
Accumulation Ratio (AUC) of IMP in Plasma
Accumulation Ratio in plasma will be determined from all collected plasma samples from baseline through up to 48 hours post-dose
Measured: Part A: Up to 48 hours post-dose, Part B: Up to 48 hours post final dose on Day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2024
- Study start24 Apr 2024
- Primary completion25 Nov 2024
- Study completion25 Nov 2024
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
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- LeonaBio
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Fortrea Holdings, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06432647
- Sponsor's protocol ID
- ATH-1105-0101
- Status last verified
- Jan 2025
- First submitted
- 17 May 2024
- Last updated
- 23 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ATH-1105 A Phase 1, Double-Blind, Placebo-Controlled, Single-and-Multiple-Oral-Dose, Safety, Tolerability, and Pharmacokinetic Study in Healthy Male and Female Subjects
- ClinicalTrials.gov ID
- NCT06432647
- Acronym / sponsor ID
- ATH-1105-0101
- Conditions
- Healthy Volunteers
- Keywords
- ATH-1105
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- LeonaBioIndustry (pharma, biotech, devices)
- Collaborators
- Fortrea Holdings, Inc.
- Study start
- 24 Apr 2024 (actual)
- Primary completion
- 25 Nov 2024 (actual)
- Study completion
- 25 Nov 2024 (actual)
- First posted
- 29 May 2024 (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.
The goal of this Phase 1 interventional study is to assess the safety, tolerability and pharmacokinetics of ATH-1105 in healthy male and female participants.
Detailed description
The study is a Phase 1, First-In-Human study consisting of two parts (A and B). Part A will comprise a single-dose, double-blind, placebo-controlled, sequential-group design. Part B will comprise a multiple-dose, placebo-controlled, sequential-group design.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ATH-1105 | Experimental | Drug: ATH-1105Part A: ATH-1105 administered once as an oral solution. Part B: ATH-1105 administered once daily as an oral solution for 10 days. |
| Placebo | Placebo comparator | Drug: PlaceboPart A: Placebo administered once as an oral solution Part B: Placebo administered once daily as an oral solution |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Body mass index between 18.0 and 32.0 kg/m2 inclusive.
- In good health, determined by no clinically significant findings from medical history, 12-lead ECG, vital signs measurements, and clinical laboratory evaluations at screening and check-in or predose on Day 1
- Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception
- Able to comprehend and willing to sign an ICF and to abide by the study restrictions.
Key exclusion criteria (19 listed)
- Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder
- History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance
- History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs
- Any of the following:
- Confirmed systolic blood pressure >140 or <90 mmHg, diastolic blood pressure >90 or <50 mmHg, and pulse rate >100 or <40 beats per minute.
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-1105ATH-1105 in oral form. Participants will be administered ATH-1105 once in Part A and once daily for 10 days in Part B. | Drug | ATH-1105 |
| PlaceboPlacebo in oral form. Participants will be administered Placebo once in Part A and once daily for 10 days in Part B. | Drug | Placebo |
Primary outcome
Incidence of Treatment-Emergent Adverse Events
Time frame: Part A: Up to 7 days post-dose, Part B: Up to 7 days post final dose on day 10
Safety and tolerability of single or multiple ascending doses of ATH-1105 as measured by incidence of AEs, determined by clinical laboratory tests, physical examinations, vital signs measurements, and 12-lead ECG
Severity of Treatment-Emergent Adverse Events
Time frame: Part A: Up to 7 days post-dose, Part B: Up to 7 days post final dose on day 10
Treatment-emergent adverse events will be graded on a 1 through 5 scale, based on severity as determined by the principal investigator.
8 secondary outcomes
Area under the plasma concentration time curve (AUC)
Time frame: Part A: Up to 48 hours post-dose, Part B: Up to 48 hours post final dose on Day 10
Maximum observed plasma concentration (Cmax)
Time frame: Part A: Up to 48 hours post-dose, Part B: Up to 48 hours post final dose on Day 10
Time to maximum observed plasma concentration (Tmax)
Time frame: Part A: Up to 48 hours post-dose, Part B: Up to 48 hours post final dose on Day 10
Half-life (t1/2)
Time frame: Part A: Up to 48 hours post-dose, Part B: Up to 48 hours post final dose on Day 10
Amount of IMP excreted unchanged in the urine (Ae)
Time frame: Part A: Up to 48 hours post-dose, Part B: Up to 48 hours post final dose on Day 10
IMP Concentration in Cerebrospinal Fluid
Time frame: Will occur at calculated maximum plasma concentration.
Accumulation Ratio (AUC) of IMP in Urine
Time frame: Part A: Up to 48 hours post-dose, Part B: Up to 48 hours post final dose on Day 10
Accumulation Ratio (AUC) of IMP in Plasma
Time frame: Part A: Up to 48 hours post-dose, Part B: Up to 48 hours post final dose on Day 10
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 23 Jan 2025.
- Individual participant dataSharing planned: No
Related trials for Healthy Volunteers
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
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-1105 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 4 inclusion and 19 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 23 Jan 2025. 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 (time frame: Part A: Up to 7 days post-dose, Part B: Up to 7 days post final dose on day 10). The study lists 2 primary outcomes in all. 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 23 Jan 2025.