A First-In-Human SAD and MAD Study to Evaluate the Safety, Tolerability, PK and PD of SC Administered ALTB-268 in Healthy Volunteers

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Biological: ALTB-268
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Study consists of 2 parts: Part A: a single ascending dose (SAD) and Part B: multiple ascending dose (MAD).
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ALTB-268<br>Subcutaneous dose in healthy volunteers | Biological: ALTB-268<br>* monoclonal antibody<br>|
| Placebo Comparator: Placebo<br>Subcutaneous dose in healthy volunteers | Other: Placebo<br>* formulation buffer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | through study completion, up to day 120 of the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics of ALTB-268 AUC (PK) of sc administered ALTB-268 in healthy volunteers. | Including AUC0-t, AUC0-inf, AUC0-tau | through study completion, up to day 120 of the study | 
| Pharmacokinetics of ALTB-268 Cmax | Maximum plasma concentration | through study completion, up to day 120 of the study | 
| Pharmacokinetics of ALTB-268 tmax | Time to reach Cmax | through study completion, up to day 120 of the study | 
| Pharmacokinetics of ALTB-268 t1/2 | Half life | through study completion, up to day 120 of the study | 
| Pharmacokinetics of ALTB-268 CL/F | Apparent clearance, calculated as dose/AUC0-inf | 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 | through study completion, up to day 120 of the study |