Clinical trial NCT05215912: A Single and Multiple Dosing Study Targeting Biparatopic Antibody CD38 in Healthy Volunteers
Official title: A Phase 1, Double-blind, Single- and Multiple-ascending Dose Escalation Study of TNB-738, a Biparatopic Antibody Targeting CD38 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Keywords: CD38
Lead sponsor: Ancora Biotech LLC
Sponsor class: INDUSTRY
Collaborators: name: Novotech (Australia) Pty Limited
First posted: 2022-01-31
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Phase 1, Double blind, Single ascending and Multiple ascending dose (SAD and MAD) escalation study in Healthy Volunteers.

Detailed description: TNB-738 is a fully human bispecific antibody used to inhibit human CD38 enzyme.

The study will consist of 2 arms (A and B). The SAD arm (Arm A) of the study consists of sequential single dose escalation cohorts, whereas the MAD portion (Arm B) of the study consists of sequential dose escalation cohorts receiving study drug once every 4 weeks for 3 doses. In both Arm A and Arm B, subjects will be randomized to receive either TNB-738 or matching placebo.

Eligibility criteria: Inclusion Criteria:

1. Healthy male or female
2. Age 18 - 75
3. Body mass index (BMI) ranging between 18 and 35 kg/m2, inclusive
4. Female subjects of child-bearing potential must agree to use one of the study-approved effective contraceptive methods for the duration of the study
5. Male subjects must practice true abstinence or agree to use a condom while participating in the study through End of study (EOS)
6. If female, a negative serum pregnancy test at Screening and urinary pregnancy test at Day -1 is required
7. Able to read, understand, and provide signed informed consent
8. Able to communicate adequately with the investigator and to comply with the requirements for the entire study.

Exclusion Criteria:

1. Subject has any significant medical condition that would prevent the subject from participating in the study.
2. Subject is pregnant or breastfeeding.
3. Subject is currently receiving treatment with a biologic agent.
4. Subject has a history of anaphylactic reactions to biologic agents.
5. Subject has been dosed with another investigational drug study within 60 days prior to study drug administration.
6. Subject has current or recent (within 4 weeks prior to screening) signs or symptoms of infection that require antibiotic administration.
7. Subject has evidence of COVID-19 infection and/or subject is deemed at risk for the coronavirus disease in the opinion of the investigator or the subject has participated in another clinical study involving treatment(s), which may increase such risk.
8. Subject has used any prescription (excluding hormonal birth control) drugs within 14 days or illicit drugs within 30 days, or 5 half-lives (whichever is longer), prior to study drug administration.
9. Subject has a positive urine drug test or alcohol breath test at screening.
10. Subject has donated or lost more than 1 unit of blood (500 mL) within 60 days or more than 1 unit of serum within 7 days before the study drug administration.
11. Subject is HIV, HBV, or HCV positive.
12. Subject has received a live virus vaccine within 4 weeks of dosing

Primary outcomes:
measure: Safety and tolerability of TNB-738 by the incidence of treatment emergent adverse events in Single Ascending group. Adverse Events will be graded according to the NCI-CTCAE, version 5.0
timeFrame: 13 weeks
measure: Safety and tolerability of TNB-738 by the incidence of treatment emergent adverse events in Multiple Ascending group. Adverse Events will be graded according to the NCI-CTCAE, version 5.0
timeFrame: 21 weeks
measure: To investigate the Cmax (maximum Serum concentration) of TNB-738 following Single Ascending Dose.
timeFrame: 13 weeks
measure: To investigate the Cmax (Maximum Serum concentration) of TNB-738 following Multiple Ascending Dose
timeFrame: 21 weeks
measure: Tmax (time for maximum serum concentration) for Single Ascending Dose
timeFrame: 13 weeks
measure: Tmax (time for maximum serum concentration) for Multiple Ascending Dose
timeFrame: 21 weeks
measure: Terminal elimination half-life (t1/2) for Single Ascending Dose
timeFrame: 13 weeks
measure: Terminal elimination half-life (t1/2) for Multiple Ascending Dose
timeFrame: 21 weeks
Secondary outcomes:
measure: Anti drug antibodies (ADA) as a measurement of immunogenicity following Single Ascending Dose of TNB-738
timeFrame: 13 weeks
measure: Anti drug antibodies (ADA) as a measurement of immunogenicity following Multiple Ascending Dose of TNB-738
timeFrame: 21 weeks
measure: To determine CD38 enzyme activity following Single Ascending Dose
timeFrame: 13 weeks
measure: To determine CD38 enzyme activity following Multiple Ascending Dose
timeFrame: 21 weeks
Other outcomes:
Locations:
city: Herston
country: Australia
facility: Q-Pharm Pty Ltd
state: Queensland
Study officials:
affiliation: TeneoFour Inc.
name: Ben Buelow, MD, PhD
role: STUDY_DIRECTOR
References: