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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06625671




Registration number
NCT06625671
Ethics application status
Date submitted
20/09/2024
Date registered
3/10/2024
Date last updated
3/10/2024

Titles & IDs
Public title
A Phase 1 Study of DB-2304 in Healthy Adults
Scientific title
A Randomized, Double-Blind, Placebo- and Positive-Controlled, Single Ascending Dose Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DB-2304 Injection in Healthy Adult Participants
Secondary ID [1] 0 0
DB-2304-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Autoimmune Diseases 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - DB-2304
Treatment: Drugs - Placebo

Experimental: Dose Level 1 -

Experimental: Dose Level 2 -

Experimental: Dose Level 3 -

Experimental: Dose Level 4 -

Experimental: Dose Level 5 -


Treatment: Drugs: DB-2304
DB-2304

Treatment: Drugs: Placebo
Placebo
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
TEAEs
Timepoint [1] 0 0
Up to 56 days after last study treatment administration
Primary outcome [2] 0 0
SAEs
Timepoint [2] 0 0
Up to 56 days after last study treatment administration
Primary outcome [3] 0 0
ECG parameters
Timepoint [3] 0 0
Up to 56 days after last study treatment administration
Primary outcome [4] 0 0
Weight measurements
Timepoint [4] 0 0
Up to 56 days after last study treatment administration
Primary outcome [5] 0 0
Heart Rate measurements
Timepoint [5] 0 0
Up to 56 days after last study treatment administration
Primary outcome [6] 0 0
Pulse rate measurements
Timepoint [6] 0 0
Up to 56 days after last study treatment administration
Primary outcome [7] 0 0
Respiratory rate measurements
Timepoint [7] 0 0
Up to 56 days after last study treatment administration
Primary outcome [8] 0 0
Body temperature measurements
Timepoint [8] 0 0
Up to 56 days after last study treatment administration

Eligibility
Key inclusion criteria
1. Participants who fully understand the purpose, nature, method, and potential adverse reac-tions of the study and voluntarily sign the informed consent form (ICF) and agree to partic-ipate.
2. Healthy male or female participants; 18 to 55 years of age (both inclusive) on the day of signing ICF; meet the body mass index (BMI) criteria.
3. Based on the investigator assessment, there are no abnormal findings or findings with clinical significance from the medical history consultation, physical examination, vital signs assessment, clinical laboratory tests, and 12-lead ECG.
4. Female participants of childbearing potential or male participants agree to use highly effective contraception during the study.
5. Participants who are willing and able to comply with the prescribed protocol treatment and evaluations
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Evidence or history of clinically significant diseases.
2. History of herpes zoster (shingles) or recurrent herpes simplex (e.g., oral cold sores or gen-ital sores).
3. Any active or suspected bacterial, viral, fungal, or parasitic infection within 30 days prior to dosing.
4. History of sensitivity to any ingredients of DB-2304.
5. Participants who have undergone surgery within the past 3 months or have plans for sur-gery during the study.

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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
4/10/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
5/06/2026
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Site AUS01-0 - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
DualityBio Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
A Randomized, Double-Blind, Placebo- and Positive-Controlled, Single Ascending Dose Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of DB-2304 Injection in Healthy
Trial website
https://clinicaltrials.gov/study/NCT06625671
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Lily Hu
Address 0 0
DualityBio Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Sally Li
Address 0 0
Country 0 0
Phone 0 0
+86 13910863858
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06625671