Clinical trial NCT05723692: A First-In-Human SAD and MAD Study to Evaluate the Safety, Tolerability, PK and PD of SC Administered ALTB-268 in Healthy Volunteers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: AltruBio Inc.
Sponsor class: INDUSTRY
Collaborators: name: ICON plc
First posted: 2023-02-13
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Study consists of 2 parts: Part A: a single ascending dose (SAD) and Part B: multiple ascending dose (MAD).
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

1. Written Informed Consent and willingness to comply with the study restrictions.
2. Sex: male or female volunteers.
3. Age: 18 to 55 years, inclusive, at screening.
4. Body mass index (BMI): 18.0 to 32.0 kg/m2, inclusive, at screening.
5. Weight: 50 kg to 110 kg, inclusive, at screening.
6. 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

Exclusion Criteria:

1. 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.
2. Use of any investigational drug or device within 30 days or five half-lives whichever is longer, of the first dose of study drug.
3. Any disease which, in the opinion of the Investigator, poses an unacceptable risk to the volunteers.
4. 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.

Primary outcomes:
measure: Incidence of ALTB-268 Treatment-Emergent Adverse Events
timeFrame: through study completion, up to day 120 of the study
Secondary outcomes:
measure: Pharmacokinetics of ALTB-268 AUC (PK) of sc administered ALTB-268 in healthy volunteers.
timeFrame: through study completion, up to day 120 of the study
measure: Pharmacokinetics of ALTB-268 Cmax
timeFrame: through study completion, up to day 120 of the study
measure: Pharmacokinetics of ALTB-268 tmax
timeFrame: through study completion, up to day 120 of the study
measure: Pharmacokinetics of ALTB-268 t1/2
timeFrame: through study completion, up to day 120 of the study
measure: Pharmacokinetics of ALTB-268 CL/F
timeFrame: through study completion, up to day 120 of the study
measure: Pharmacokinetics of ALTB-268 Rac
timeFrame: through study completion, up to day 120 of the study
Other outcomes:
measure: Pharmacodynamics of ALTB-268 Receptor Occupancy
timeFrame: through study completion, up to day 120 of the study
measure: Exploratory Immunophenotyping Lymphocyte subsets
timeFrame: through study completion, up to day 120 of the study
measure: Pharmacodynamics - change in target engagement biomarkers
timeFrame: through study completion, up to day 120 of the study
Locations:
city: Lenexa
country: United States
facility: ICON Early Development Services
state: Kansas
Study officials:
affiliation: ICON plc
name: Daniel Dickerson, MD
role: PRINCIPAL_INVESTIGATOR
References: