Healthy VolunteersPhase 1NCT05723692
A First-In-Human SAD and MAD Study to Evaluate the Safety, Tolerability, PK and PD of SC Administered ALTB-268 in Healthy Volunteers
A Phase 1 study testing ALTB-268 in people with Healthy Volunteers, run by AltruBio Inc. at 1 site in United States.
Trial summary
This study with ALTB-268 will determine the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple ascending doses of ALTB-268 in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- ALTB-268
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jan 2023to 27 Oct 2023
- 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
- Written Informed Consent and willingness to comply with the study restrictions.
- Sex: male or female volunteers.
- Age: 18 to 55 years, inclusive, at screening.
- Body mass index (BMI): 18.0 to 32.0 kg/m2, inclusive, at screening.
- Weight: 50 kg to 110 kg, inclusive, at screening.
- Healthy volunteers: Healthy status as defined by the absence of evidence of any clinically significant, in the opinion of the Investigator, active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead ECG, hematology, blood chemistry, serology, and urinalysis
Who cannot join
- Males with female partners who are pregnant, lactating, or planning to become pregnant during this study or within 90 days after dosing of study drug.
- Use of any investigational drug or device within 30 days or five half-lives whichever is longer, of the first dose of study drug.
- Any disease which, in the opinion of the Investigator, poses an unacceptable risk to the volunteers.
- Clinically significant history of any drug sensitivity, drug allergy, or food allergy, as determined by the Investigator (such as anaphylaxis, hepatotoxicity, or treatment with steroids or epinephrine). Confirmatory circumstances would include treatment with epinephrine or in emergency department.
Trial locations and contacts
1 site in 1 country.
United States1 site
ICON Early Development Services
Lenexa, Kansas, 66219
About this study
Official title: A First-In-Human, Randomized, Double-Blind, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneously Administered ALTB-268 in Healthy Volunteers
This study with ALTB-268 will determine the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple ascending doses of ALTB-268 in healthy volunteers.
Read the detailed description
This is a Phase I, first-in-human, randomized, double-blind, single and multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneously administered ALTB-268 in healthy volunteers. Up to 40 and 24 healthy volunteers will be recruited in single and multiple ascending doses, respectively.
The primary objective is to assess the safety and tolerability of subcutaneously (sc) administered ALTB-268 in healthy volunteers. The secondary objective is to assess the plasma pharmacokinetics of sc administered ALTB-268 in healthy volunteers. The exploratory objectives are to assess the pharmacodynamics and evaluate immunogenicity of sc administered ALTB-268 in healthy volunteers.
- Conditions
- Healthy Volunteers
- Being tested
- ALTB-268, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALTB-268Biological
monoclonal antibody
PlaceboOther
formulation buffer
| Study group | Role | What they receive |
|---|---|---|
| ALTB-268 | Experimental | Subcutaneous dose in healthy volunteers Receives: Biological: ALTB-268 |
| Placebo | Placebo comparator | Subcutaneous dose in healthy volunteers Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of ALTB-268 Treatment-Emergent Adverse Events
Adverse events (AEs) - severity of the AEs will be graded using the most current version of the Common Terminology Criteria for AE (CTCAE) (V5.0) 5-point scale. The relationship between AEs and the study drug will be indicated as related or not related.
Measured: through study completion, up to day 120 of the study
Secondary outcomes (6)
Pharmacokinetics of ALTB-268 AUC (PK) of sc administered ALTB-268 in healthy volunteers.
Including AUC0-t, AUC0-inf, AUC0-tau
Measured: through study completion, up to day 120 of the study
Pharmacokinetics of ALTB-268 Cmax
Maximum plasma concentration
Measured: through study completion, up to day 120 of the study
Pharmacokinetics of ALTB-268 tmax
Time to reach Cmax
Measured: through study completion, up to day 120 of the study
Pharmacokinetics of ALTB-268 t1/2
Half life
Measured: through study completion, up to day 120 of the study
Pharmacokinetics of ALTB-268 CL/F
Apparent clearance, calculated as dose/AUC0-inf
Measured: through study completion, up to day 120 of the study
Pharmacokinetics of ALTB-268 Rac
The ratio of accumulation of a drug after repeated administration as compared to a single dose, PART B only
Measured: through study completion, up to day 120 of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start17 Jan 2023
- Primary completion27 Oct 2023
- Study completion27 Oct 2023
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
- Model description
- Study consists of 2 parts: Part A: a single ascending dose (SAD) and Part B: multiple ascending dose (MAD).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- AltruBio Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ICON plc
- Responsible party
- Sponsor
- Investigators
- Daniel Dickerson, MD, Principal investigator, ICON plc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05723692
- Sponsor's protocol ID
- ALTB-268-101
- Status last verified
- Feb 2024
- First submitted
- 20 Jan 2023
- Last updated
- 6 Feb 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-In-Human, Randomized, Double-Blind, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneously Administered ALTB-268 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05723692
- Acronym / sponsor ID
- ALTB-268-101
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- AltruBio Inc.Industry (pharma, biotech, devices)
- Collaborators
- ICON plc
- Study start
- 17 Jan 2023 (actual)
- Primary completion
- 27 Oct 2023 (actual)
- Study completion
- 27 Oct 2023 (actual)
- First posted
- 13 Feb 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 study with ALTB-268 will determine the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple ascending doses of ALTB-268 in healthy volunteers.
Detailed description
This is a Phase I, first-in-human, randomized, double-blind, single and multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneously administered ALTB-268 in healthy volunteers. Up to 40 and 24 healthy volunteers will be recruited in single and multiple ascending doses, respectively.
The primary objective is to assess the safety and tolerability of subcutaneously (sc) administered ALTB-268 in healthy volunteers. The secondary objective is to assess the plasma pharmacokinetics of sc administered ALTB-268 in healthy volunteers. The exploratory objectives are to assess the pharmacodynamics and evaluate immunogenicity of sc administered ALTB-268 in healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Study consists of 2 parts: Part A: a single ascending dose (SAD) and Part B: multiple ascending dose (MAD).
| Arm | Type | Receives |
|---|---|---|
| ALTB-268 | Experimental | Biological: ALTB-268Subcutaneous dose in healthy volunteers |
| Placebo | Placebo comparator | Other: PlaceboSubcutaneous dose in healthy volunteers |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Written Informed Consent and willingness to comply with the study restrictions.
- Sex: male or female volunteers.
- Age: 18 to 55 years, inclusive, at screening.
- Body mass index (BMI): 18.0 to 32.0 kg/m2, inclusive, at screening.
- Weight: 50 kg to 110 kg, inclusive, at screening.
Key exclusion criteria (4 listed)
- Males with female partners who are pregnant, lactating, or planning to become pregnant during this study or within 90 days after dosing of study drug.
- Use of any investigational drug or device within 30 days or five half-lives whichever is longer, of the first dose of study drug.
- Any disease which, in the opinion of the Investigator, poses an unacceptable risk to the volunteers.
- Clinically significant history of any drug sensitivity, drug allergy, or food allergy, as determined by the Investigator (such as anaphylaxis, hepatotoxicity, or treatment with steroids or epinephrine). Confirmatory circumstances would include treatment with epinephrine or in emergency department.
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 |
|---|---|---|
| ALTB-268monoclonal antibody | Biological | ALTB-268 |
| Placeboformulation buffer | Other | Placebo |
Primary outcome
Incidence of ALTB-268 Treatment-Emergent Adverse Events
Time frame: through study completion, up to day 120 of the study
Adverse events (AEs) - severity of the AEs will be graded using the most current version of the Common Terminology Criteria for AE (CTCAE) (V5.0) 5-point scale. The relationship between AEs and the study drug will be indicated as related or not related.
6 secondary outcomes
Pharmacokinetics of ALTB-268 AUC (PK) of sc administered ALTB-268 in healthy volunteers.
Time frame: through study completion, up to day 120 of the study
Pharmacokinetics of ALTB-268 Cmax
Time frame: through study completion, up to day 120 of the study
Pharmacokinetics of ALTB-268 tmax
Time frame: through study completion, up to day 120 of the study
Pharmacokinetics of ALTB-268 t1/2
Time frame: through study completion, up to day 120 of the study
Pharmacokinetics of ALTB-268 CL/F
Time frame: through study completion, up to day 120 of the study
Pharmacokinetics of ALTB-268 Rac
Time frame: through study completion, up to day 120 of the study
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 6 Feb 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.
Daniel Dickerson, MD principal investigator
ICON plc
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 ALTB-268 in people with Healthy Volunteers, run by AltruBio 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 6 inclusion and 4 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 6 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 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 ALTB-268 Treatment-Emergent Adverse Events (time frame: through study completion, up to day 120 of the study). 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 6 Feb 2024.