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 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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Biological: ALTB-268; Other: Placebo

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 Type: Interventional
• Enrollment (Actual): 56
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Lenexa, Kansas, United States, 66219
      • ICON Early Development Services

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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 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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacodynamics of ALTB-268 Receptor Occupancy	Receptor Occupancy will be measured using a flow cytometry based method	through study completion, up to day 120 of the study
Exploratory Immunophenotyping Lymphocyte subsets	Lymphocyte subsets, T,B and NK cells will be assessed using a flow cytometry based method	through study completion, up to day 120 of the study
Pharmacodynamics - change in target engagement biomarkers	inhibition of cytokine release from ex-vivo stimulated T cells and the change of soluble (free) PSGL-1 molecule	through study completion, up to day 120 of the study

Collaborators and Investigators

• Sponsor: AltruBio Inc.
• Collaborators: ICON plc
• Investigators: Principal Investigator: Daniel Dickerson, MD, ICON plc

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2023
• Primary Completion (Actual): October 27, 2023
• Study Completion (Actual): October 27, 2023

Study Registration Dates

• First Submitted: January 20, 2023
• First Submitted That Met QC Criteria: February 9, 2023
• First Posted (Actual): February 13, 2023

Study Record Updates

• Last Update Posted (Estimated): February 6, 2024
• Last Update Submitted That Met QC Criteria: February 4, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: ALTB-268-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No