HealthyPhase 1NCT05756920
This is a Study to Evaluate the Safety, Tolerability, PK and PD of IV Administered ABL301 in Healthy Adult Participants
A Phase 1 study testing ABL301 in people with Healthy, run by ABL Bio, Inc. at 1 site in United States.
Trial summary
This is a Phase 1, FIH, randomized, double-blind, placebo-controlled study designed to assess the safety, tolerability, PK and PD after SAD and MAD in healthy adult participants. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- ABL301
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 91 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Dec 2022to 30 Apr 2025
- 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
- The participant is considered by the investigator to be in good health as determined by medical history, clinical laboratory test results (including urinalysis), physical and neurological examination, vital signs, and ECG.
- The participant agrees to comply with all protocol requirements.
- The participant is a healthy male or female 18 to 55 years of age, inclusive.
- The participant has body weight ≥50 kg and a BMI of 19 to 30 kg/m2, inclusive.
Who cannot join
- The participant has a history of cardiovascular disease (eg, hypertension, arrhythmia, heart failure, long QT syndrome, or other conditions/diseases causing prolongation of the QT/QTcF).
- The participant has a past medical history of clinically significant ECG abnormalities or a family history of a prolonged QT interval syndrome prior to initial dosing.
- The participant has frequent headaches and/or migraine or recurrent nausea and/or vomiting (for vomiting only: more than twice a month).
- The participant has history of malignancy including solid tumors and hematologic malignancies within 5 years prior to the screening visit (except basal cell and squamous cell carcinomas of the skin that had been completely excised and were considered cured).
- The participant has a history of clinically significant drug or food allergies, as determined by the investigator.
- (MAD only) The participant has a current psychiatric disorder, suicidal ideation in the previous 6 months (as assessed by the C SSRS), or a lifetime suicide attempt.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Randomized, A Phase 1 Randomized, Placebo Controlled, Double Blind, Two Part, Single- and Multiple-Ascending-Dose Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenously Administered ABL301 in Healthy Adult Participants
This is a Phase 1, FIH, randomized, double-blind, placebo-controlled study designed to assess the safety, tolerability, PK and PD after SAD and MAD in healthy adult participants.
Read the detailed description
The present study is the first administration of ABL301 in humans. This study will evaluate safety and tolerability and characterize the pharmacokinetic (PK) and pharmacodynamic (PD) profile of ABL301, following IV single ascending dose (Part 1 - SAD), and multiple ascending dose (Part 2 - MAD) administrations, in healthy adult participants.
In Part 1 SAD, seven single doses are planned to be administered in an ascending manner: DL1, DL2, DL3, DL4, DL5, DL6 and DL7. Each dose level will comprise 8 participants randomly assigned in an overall 6:2 ratio (ABL301:Placebo), including 1:1 ratio for the first 2 sentinel participants and 5:1 ratio for the remaining participants, to receive a single dose of study drug or placebo, respectively.
In Part 2 MAD, three multiples doses are planned to be administered in an ascending manner: DL1, DL2 and DL3. Each dose level will comprise 10 participants randomly assigned in an overall 8:2 ratio (ABL301:Placebo)
- Conditions
- Healthy
- Being tested
- ABL301, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABL301Drug
SAD: Participants will receive a single dose of ABL301 IV infusion, MAD: Participants will receive multiple doses of ABL301 IV infusion
PlaceboDrug
SAD: single Placebo IV infusion, MAD: multiple Placebo IV infusion
| Study group | Role | What they receive |
|---|---|---|
| ABL301 | Experimental | Not described Receives: Drug: ABL301 |
| Placebo | Placebo comparator | Not described 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
Number of participants with AEs
Measured: Day 1 to Day 113 for SAD Part and D1 to Day 169 for MAD Part
Secondary outcomes (5)
Assessment of pharmacokinetic(PK) parameter Cmax in serum
Maximum plasma concentration observed
Measured: Day 1 to Day 113 for SAD Part and D1 to Day 169 for MAD Part
Assessment of pharmacokinetic(PK) parameter AUClast in serum
Area under the plasma concentration versus time curve from time zero to the real time tlast
Measured: Day 1 to Day 113 for SAD Part and D1 to Day 169 for MAD Part
Assessment of immunogenicity
Numbers of subjects with ADA(anti-drug antibody) positive
Measured: Day 1 to Day 113 for SAD Part and D1 to Day 169 for MAD Part
Assessment of immunogenicity
Numbers of subjects with ADA(anti-drug antibody) negative
Measured: Day 1 to Day 113 for SAD Part and D1 to Day 169 for MAD Part
Assessment of pharmacokinetic(PK) parameter AUCtau in serum (MAD only)
Area under the serum concentration time curve over the dosing interval
Measured: D1 to Day 169 for MAD Part
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2023
- Study start31 Dec 2022
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Model description
- Single Ascending Dose and Multiple Ascending Dose
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- ABL Bio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05756920
- Sponsor's protocol ID
- ABL301-1001
- Status last verified
- Jul 2025
- First submitted
- 20 Jan 2023
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: ABL Bio will not be sharing individual de-identified participant data or other relevant study documents.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Randomized, A Phase 1 Randomized, Placebo Controlled, Double Blind, Two Part, Single- and Multiple-Ascending-Dose Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenously Administered ABL301 in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT05756920
- Acronym / sponsor ID
- ABL301-1001
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- ABL Bio, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Dec 2022 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 7 Mar 2023 (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 is a Phase 1, FIH, randomized, double-blind, placebo-controlled study designed to assess the safety, tolerability, PK and PD after SAD and MAD in healthy adult participants.
Detailed description
The present study is the first administration of ABL301 in humans. This study will evaluate safety and tolerability and characterize the pharmacokinetic (PK) and pharmacodynamic (PD) profile of ABL301, following IV single ascending dose (Part 1 - SAD), and multiple ascending dose (Part 2 - MAD) administrations, in healthy adult participants.
In Part 1 SAD, seven single doses are planned to be administered in an ascending manner: DL1, DL2, DL3, DL4, DL5, DL6 and DL7. Each dose level will comprise 8 participants randomly assigned in an overall 6:2 ratio (ABL301:Placebo), including 1:1 ratio for the first 2 sentinel participants and 5:1 ratio for the remaining participants, to receive a single dose of study drug or placebo, respectively.
In Part 2 MAD, three multiples doses are planned to be administered in an ascending manner: DL1, DL2 and DL3. Each dose level will comprise 10 participants randomly assigned in an overall 8:2 ratio (ABL301:Placebo)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Single Ascending Dose and Multiple Ascending Dose
| Arm | Type | Receives |
|---|---|---|
| ABL301 | Experimental | Drug: ABL301 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- The participant is considered by the investigator to be in good health as determined by medical history, clinical laboratory test results (including urinalysis), physical and neurological examination, vital signs, and ECG.
- The participant agrees to comply with all protocol requirements.
- The participant is a healthy male or female 18 to 55 years of age, inclusive.
- The participant has body weight ≥50 kg and a BMI of 19 to 30 kg/m2, inclusive.
Key exclusion criteria (6 listed)
- The participant has a history of cardiovascular disease (eg, hypertension, arrhythmia, heart failure, long QT syndrome, or other conditions/diseases causing prolongation of the QT/QTcF).
- The participant has a past medical history of clinically significant ECG abnormalities or a family history of a prolonged QT interval syndrome prior to initial dosing.
- The participant has frequent headaches and/or migraine or recurrent nausea and/or vomiting (for vomiting only: more than twice a month).
- The participant has history of malignancy including solid tumors and hematologic malignancies within 5 years prior to the screening visit (except basal cell and squamous cell carcinomas of the skin that had been completely excised and were considered cured).
- The participant has a history of clinically significant drug or food allergies, as determined by the investigator.
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 |
|---|---|---|
| ABL301SAD: Participants will receive a single dose of ABL301 IV infusion, MAD: Participants will receive multiple doses of ABL301 IV infusion | Drug | ABL301 |
| PlaceboSAD: single Placebo IV infusion, MAD: multiple Placebo IV infusion | Drug | Placebo |
Primary outcome
Incidence of Treatment-Emergent Adverse Events
Time frame: Day 1 to Day 113 for SAD Part and D1 to Day 169 for MAD Part
Number of participants with AEs
5 secondary outcomes
Assessment of pharmacokinetic(PK) parameter Cmax in serum
Time frame: Day 1 to Day 113 for SAD Part and D1 to Day 169 for MAD Part
Assessment of pharmacokinetic(PK) parameter AUClast in serum
Time frame: Day 1 to Day 113 for SAD Part and D1 to Day 169 for MAD Part
Assessment of immunogenicity
Time frame: Day 1 to Day 113 for SAD Part and D1 to Day 169 for MAD Part
Assessment of immunogenicity
Time frame: Day 1 to Day 113 for SAD Part and D1 to Day 169 for MAD Part
Assessment of pharmacokinetic(PK) parameter AUCtau in serum (MAD only)
Time frame: D1 to Day 169 for MAD Part
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 Jul 2025.
- Individual participant dataSharing planned: No. ABL Bio will not be sharing individual de-identified participant data or other relevant study documents.
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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 ABL301 in people with Healthy, run by ABL Bio, Inc. 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 6 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 Jul 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: Day 1 to Day 113 for SAD Part and D1 to Day 169 for MAD Part). 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 Jul 2025.