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Trial registered on ANZCTR


Registration number
ACTRN12624000054516p
Ethics application status
Submitted, not yet approved
Date submitted
14/12/2023
Date registered
23/01/2024
Date last updated
23/01/2024
Date data sharing statement initially provided
23/01/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
A First-in-Human Study of SGB-9768 in Healthy Volunteers
Scientific title
A Phase 1, Randomized, Double-blind, Placebo-Controlled Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered SGB-9768 in Healthy Volunteers
Secondary ID [1] 311163 0
SGB-9768-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Complement-mediated Diseases 332328 0
Condition category
Condition code
Inflammatory and Immune System 329040 329040 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - SGB-9768
6 Cohorts: 25mg, 50mg, 100mg, 200mg, 400mg and 800mg
The duration of administration: single dose
SGB-9768 will be administered via subcutaneous injection by a registered nurse
The used and/or partially used vials can be disposed of per local practice. If the used and/or partially used vials cannot be disposed of at the site, they will be returned, along with the unused vials, to the sponsor or its agent after receipt of written authorization from the Sponsor.
Intervention code [1] 327605 0
Treatment: Drugs
Comparator / control treatment
Sodium chloride injection (0.9% w/v) will be administered via subcutaneous injection as a single dose.
Control group
Placebo

Outcomes
Primary outcome [1] 336846 0
Safety and tolerability
Timepoint [1] 336846 0
Baseline, 2, 3, 5, 8, 15, 22, 29, 43, 57, 71, 85, 131, 141, and 169 days after intervention commencement, and 225, 281, 337 days after intervention commencement if C3 level has not reached 60% of baseline and below normal range.
Secondary outcome [1] 429818 0
Pharmacokinetic paremeters
Timepoint [1] 429818 0
0, 0.5, 1, 2, 4, 6, 8, 12, 24, 48h post-dose
Secondary outcome [2] 429819 0
Pharmacodynamic effect
Timepoint [2] 429819 0
Predose, 3, 5, 8, 15, 22, 29, 43, 57, 71, 85, 113, 141, 169 days after intervention commencement. And 225, 281, 337 days after intervention commencement if C3 level has not reached 60% of baseline and below normal range.

Eligibility
Key inclusion criteria
1. Male and female subjects aged 18 to 55 years are included at the time of informed consent.
2. Body mass index between 18 and 32 kg/m2 at screening, inclusive.
3. Physical examination, vital signs, 12-lead electrocardiogram, and laboratory tests be normal or slightly abnormal but not clinically significant according to Investigator’s judgement.
4. Healthy volunteers must be willing to be vaccinated for Neisseria meningitidis (both meningococcal group ACWY conjugate vaccine and meningococcal group B vaccine), Haemophilus influenzae, and Streptococcus pneumoniae before dosing, and willing to receive prophylactic antibiotics as required in the protocol.
5. Female subjects must be non-pregnant or non-lactating.
6. Women of child-bearing potential who are not exclusively in same-sex relationships and males with partners of child-bearing potential must agree to use adequate contraception (As described in Appendix 1) from signing the informed consent until 12 weeks after completion of the follow-up visit.
7. Males must not donate sperm during the study and for 12 weeks after completion of the follow-up visit. Females must not donate egg and for12 weeks after completion of the follow-up visit.
8. Willing to comply with the protocol required visit schedule and visit requirements and provide written informed consent.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. A history of or current surgical or medical condition that, in the opinion of the Investigator, may put the subject at significant risk (according to Investigator’s judgment) or interfere with the subject’s participation in the clinical study.
2. History of or evidence of tuberculosis.
3. History of recurrent or chronic infections.
4. Subjects with a history of meningococcal infection, or subjects who are exposed to Neisseria meningitidis.
5. History of asplenia or splenectomy.
6. History of abnormalities in complement or hereditary complement deficiency.
7. History of receiving any type of live attenuated vaccine 30 days prior to screening or plans to have such a vaccination over the course of study.
8. Any skin condition and/or tattoo that may interfere the evaluation of safety at the injection site.
9. Presence or suspicion of active viral, bacterial, fungal, or parasitic infection within 14 days before the first study drug administration.
10. History of clinically significant tendinopathy and/or tendon rupture.
11. Serum C3 less than LLN at screening.
12. Positive result of hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab), human immunodeficiency virus (HIV) antibody, or syphilis at screening.
13. Alanine aminotransferase (ALT), total bilirubin (TBIL), aspartate aminotransferase (AST), alkaline phosphatase (ALP), or gamma-glutamyl transferase (GGT) greater than 1.5 × ULN; or, if ALT, TBIL, AST, ALP, or GGT greater than ULN, and less than or equa to 1.5 × ULN, and considered clinically relevant by the Investigator at screening, Day -14, or Day -1.
14. Creatinine (Cr) greater than ULN at screening, Day -14, or Day -1, and considered clinically relevant by the Investigator.
15. QTcF values greater than 450ms for male, and greater than 470ms for female, confirmed by repeated ECGs at screening, Day -14, or Day -1.
16. History of multiple drug allergies or allergic reactions to an oligonucleotide or N-acetylgalactosamine (GalNAc).
17. History of intolerance to subcutaneous (SC) injection or relevant abdominal scarring (surgical, burns, etc.)
18. Received an investigational agent within 30 days or 5-half-lives (whichever is longer) before the first dose of the study drug or being in other clinical study.
19. History or clinical evidence of drug abuse within 12 months before screening or positive screen for drugs of abuse.
20. Used prescribed or over-the-counter medication within 14 days or 5 half-lives (whichever is longer) before the first dose of the study drug unless determined not clinically relevant by the Investigator.
21. Alcohol consumption more than 14 standard drinks per week within one month before screening or positive screen for an alcohol breath test (1 standard drink = 10 grams of alcohol).
22. Regular tobacco use more than 5 cigarettes per day within 3 months before screening.
23. Donate more than 500 mL of blood within 90 days before the first dose of the study drug.
24. Any conditions which, in the opinion of the Investigator, would make the subject unsuitable for enrollment or could interfere with the subject’s participation in or completion of the study.

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 administering the treatment/s
The people assessing the outcomes
Intervention assignment
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/04/2024
Actual
Date of last participant enrolment
Anticipated
30/09/2024
Actual
Date of last data collection
Anticipated
30/06/2025
Actual
Sample size
Target
36
Accrual to date
Final
Recruitment outside Australia
Country [1] 26031 0
New Zealand
State/province [1] 26031 0

Funding & Sponsors
Funding source category [1] 315418 0
Commercial sector/Industry
Name [1] 315418 0
Sanegene Bio New Zealand Ltd
Country [1] 315418 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Sanegene Bio New Zealand Ltd
Address
96 St Georges Bay Road, Parnell, Auckland 1052 New Zealand
Country
New Zealand
Secondary sponsor category [1] 317481 0
Other Collaborative groups
Name [1] 317481 0
Novotech (NewZealand) Pty Ltd
Address [1] 317481 0
Level 6, 2-6 Crowhurst street, Newmarket, Auckland 1023 New Zealand
Country [1] 317481 0
New Zealand

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 314334 0
Southern Health and Disability Ethics Committees
Ethics committee address [1] 314334 0
133 Molesworth Street, Thorndon, Wellington 6011 New Zealand
Ethics committee country [1] 314334 0
New Zealand
Date submitted for ethics approval [1] 314334 0
24/11/2023
Approval date [1] 314334 0
Ethics approval number [1] 314334 0

Summary
Brief summary
This is a randomized, double-blind, placebo-controlled, single ascending dose (SAD) study evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of SGB-9768 subcutaneously administered in Healthy Subjects.The primary purpose of this study is to evaluate the safety and tolerability of SGB-9768 when administered subcutaneously as a single ascending dose in healthy volunteers. The secondary purpose of this study is to characterize and evaluate the pharmacokinetics and pharmacodynamic effect of SGB-9768 following subcutaneous administration. The SAD phase will enroll 36 healthy participants to be split into 6 cohorts, comprising 6 subjects each (4 active, 2 placeboes). Single doses of 25, 50, 100, 200, 400, and 800 mg of SBG-9768 will be administered subcutaneously. Participants will complete a total of 3 overnight stays [admission on D-1 to post-dose on D3, followed by at least 12 follow-up visits on Day 5, Day 8, Day 15, Day 22, Day 29, Day 43, Day 57, Day 85, Day 113, Day 141, and Day 169, then every 8 weeks until C3 level returns to above 60% of baseline or within normal range, but not exceed 337 days after the study drug administration.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 131218 0
Dr Alexandra Cole
Address 131218 0
Health and Disability Ethics Committees, 4/264 Antigua Street, Christchurch 8011, New Zealand
Country 131218 0
New Zealand
Phone 131218 0
+64 3 372 9477
Fax 131218 0
Email 131218 0
alex.cole@nzcr.co.nz
Contact person for public queries
Name 131219 0
Dr Alexandra Cole
Address 131219 0
Health and Disability Ethics Committees, 4/264 Antigua Street, Christchurch 8011, New Zealand
Country 131219 0
New Zealand
Phone 131219 0
+64 3 372 9477
Fax 131219 0
Email 131219 0
alex.cole@nzcr.co.nz
Contact person for scientific queries
Name 131220 0
Dr Alexandra Cole
Address 131220 0
Health and Disability Ethics Committees, 4/264 Antigua Street, Christchurch 8011, New Zealand
Country 131220 0
New Zealand
Phone 131220 0
+64 3 372 9477
Fax 131220 0
Email 131220 0
alex.cole@nzcr.co.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.