BGB-DXP604 Alone and in Combination With BGB DXP593 in Healthy Participants

• Sponsor: BeiGene (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04669262
• Collaborator: (none)
• Enrollment: 25
• Location: 1
• Arms: 2
• Actual Duration (Months): 5.1
• Patients Per Site Per Month: 4.9

Study Details

Study Description

Brief Summary

The primary objective of this study is to investigate the safety and tolerability of BGB-DXP604 alone and in combination with BGB-DXP593 in healthy participants

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: BGB-DXP604; Drug: BGB-DXP593; Drug: Placebo; Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 25 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Basic Science
• Official Title: A Phase 1, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of BGB-DXP604 Alone and in Combination With BGB DXP593 in Healthy Subjects
• Actual Study Start Date: Dec 18, 2020
• Actual Primary Completion Date: May 21, 2021
• Actual Study Completion Date: May 21, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Part 1: BGB-DXP604 Part 1A: Single low dose of BGB-DXP604 or placebo Part 1B: Single high dose of BGB-DXP604 or placebo	Drug: BGB-DXP604; Administered as intravenous (IV) infusion over 30 to 60 minutes; Drug: Placebo; Placebo to match BGB-DXP593
Experimental: Part 2 : BGB-DXP604 + BGB-DXP593 Single dose of BGB-DXP593 followed by a single dose of BGB-DXP604 or placebo	Drug: BGB-DXP604; Administered as intravenous (IV) infusion over 30 to 60 minutes; Drug: BGB-DXP593; Administered as intravenous (IV) infusion over 30 to 60 minutes; Drug: Placebo; Placebo to match BGB-DXP593; Drug: Placebo; Placebo to match BGB-DXP604

Outcome Measures

Primary Outcome Measures

1. Number of participants experiencing Adverse Events (AEs) [Up to 16 Weeks]

2. Number of participants experiencing Serious Adverse Events (SAEs) [Up to 16 Weeks]

Secondary Outcome Measures

1. Change from baseline in 12-lead electrocardiogram (ECG) corrected QT (QTc) Interval [Up to 16 Weeks]

2. Number of participants experiencing clinical laboratory abnormalities [Up to 16 Weeks]

3. Maximum observed plasma concentration (Cmax) of BGB-DXP593 [Up to 16 Weeks]

4. Maximum observed plasma concentration (Cmax) of BGB-DXP604 [Up to 16 Weeks]

5. Area under the concentration time curve until time t (AUCt) of BGB-DXP593 [Up to 16 Weeks]

6. Area under the concentration time curve until time t (AUCt) of BGB-DXP604 [Up to 16 Weeks]

7. Area under the concentration time curve extrapolated to infinity (AUCinf) of BGB-593 [Up to 16 Weeks]

8. Area under the concentration time curve extrapolated to infinity (AUCinf) of BGB-DXP604 [Up to 16 Weeks]

9. Area under the concentration time curve from zero to 29 days (AUC0-29) of BGB-DXP593 [Up to 29 Days]

10. Area under the concentration time curve from zero to 29 days (AUC0-29) of BGB-DXP604 [Up to 29 Days]

11. Time to achieve maximum observed plasma concentration (tmax) of BGB-DXP593 [Up to 16 Weeks]

12. Time to achieve maximum observed plasma concentration (tmax) of BGB-DXP604 [Up to 16 Weeks]

13. Half-life time (t1/2) of BGB-DXP593 [Up to 16 Weeks]

14. Half-life time (t1/2) of BGB-DXP604 [Up to 16 Weeks]

15. Clearance (CL) of BGB-DXP593 [Up to 16 Weeks]

16. Clearance (CL) of BGB-DXP604 [Up to 16 Weeks]

17. Volume of distribution (Vz) of BGB-DXP593 [Up to 16 Weeks]

18. Volume of distribution (Vz) of BGB-DXP604 [Up to 16 Weeks]

19. Clinical immunogenicity of BGB-DXP604 and BGB-DXP593 evaluated through the detection of anti-drug antibodies (ADAs) over time [Up to 16 Weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Key Inclusion Criteria:

1. Participants are in good general health as determined by the investigator or medically qualified designee, based on a medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring

2. Body weight ≥ 50 kg and body mass index (BMI) within the range 18 to 32 kg/m2 (inclusive)

3. Negative SARS-CoV-2 serology test

4. Negative for COVID-19 based on the nasopharyngeal or oropharyngeal swab with the method of real-time reverse transcription-polymerase chain reaction (rRT-PCR)

Key Exclusion Criteria:

Medical Histories or Conditions

1. History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs, constituting a risk to the participant when receiving the study drug; or interfering with the interpretation of data

2. Any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that has been resected with no evidence of metastatic disease for 3 years

3. Any history of a severe allergic reaction before enrollment that has a reasonable risk of recurrence during the study

4. Any chronic or clinically significant medical condition that, in the opinion of the investigator, would jeopardize the safety or rights of the participant, including but not limited to type 1 diabetes mellitus, chronic hepatitis; or clinically significant forms of: drug or alcohol abuse, asthma (except for childhood asthma), autoimmune disease, psychiatric disorders, or heart disease

5. Previous receipt of a licensed or investigational biologic agent (such as monoclonal antibodies) within 3 months or 5 half-lives (whichever is longer) before the randomization

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Q Pharm Pty Limited	Herston	Queensland	Australia	4006

Sponsors and Collaborators

• BeiGene

Investigators

• Study Director: Zhen Yao, MD, BeiGene

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: BeiGene
• ClinicalTrials.gov Identifier: NCT04669262
• Other Study ID Numbers: BGB-DXP604-101
• First Posted: Dec 16, 2020
• Last Update Posted: Jul 28, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Study Results

No Results Posted as of Jul 28, 2021