GIGA-2339 for Hepatitis B

Recruiting at 12 trial locations

Overseen By Enrikas Vainorius, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: GigaGen, Inc.

Must be taking: Nucleoside analogues

Must not be taking: Anti-coagulation therapies

Disqualifiers: HCV, HIV, Liver cirrhosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

48 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety of a new treatment, GIGA-2339, for individuals with chronic Hepatitis B. It consists of two parts: one testing a single dose and another testing multiple doses over time. Participants will receive either the treatment or a placebo (a harmless, inactive substance). Suitable candidates have had Hepatitis B for at least 6 months, are currently on stable medication, and can continue this medication throughout the study. As a Phase 1 trial, participants will be among the first to receive this new treatment, assisting researchers in understanding its effects in people.

Do I have to stop taking my current medications for the trial?

You will need to stay on your current stable dose of nucleot(s)ide analogues (a type of medication for Hepatitis B) while participating in the study.

Is there any evidence suggesting that GIGA-2339 is likely to be safe for humans?

Research has shown that GIGA-2339 is undergoing safety testing in people with chronic Hepatitis B. This treatment is in the early stages, focusing mainly on its safety for humans. Before human testing, studies demonstrated that GIGA-2339 could reduce a key protein linked to the virus. This early testing is crucial for identifying any side effects or risks.

As this treatment is in the first trial phase, information on how well people tolerate it remains limited. These early trials aim to determine the treatment's safety and identify optimal doses that avoid harm. Progression to later trial phases will indicate successful early safety tests for GIGA-2339. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Hepatitis B?

Most treatments for Hepatitis B, like antivirals such as tenofovir or entecavir, work by suppressing the virus. But GIGA-2339 stands out because it targets the virus with a new mechanism of action, potentially reducing the virus more effectively. Researchers are excited because this treatment is administered through an intravenous infusion, which may allow for more controlled and potent dosing compared to oral medications. Additionally, the ability to use both single and multiple ascending doses means there's a chance to fine-tune the treatment to maximize its benefits while minimizing side effects.

What evidence suggests that GIGA-2339 might be an effective treatment for Hepatitis B?

Research has shown that GIGA-2339 is highly effective against Hepatitis B, being over 2,000 times stronger than some current treatments. Early studies indicate that it can significantly reduce levels of HBV surface antigens, which signal infection. The trial will evaluate GIGA-2339 in two parts: Part 1 involves a Single Ascending Dose (SAD) where participants receive a single IV infusion of either GIGA-2339 or a placebo, and Part 2 involves a Multiple Ascending Dose (MAD) with multiple IV infusions. This suggests that GIGA-2339 might effectively target different virus types. Its unique combination of antibodies could also enhance the immune system's ability to fight the infection. While these results are promising, further research is needed to confirm these effects in people. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

This trial is for individuals with chronic Hepatitis B Virus infection. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and may be required to have a history of treatment, like Entecavir use.

Inclusion Criteria

I am not pregnant, breastfeeding, and if able to have children, I use effective birth control.

Serum HBsAg concentration between ≥ 100 international units per milliliter (IU/mL) and 2000 IU/mL at screening

Serum HBV deoxyribonucleic acid (DNA) concentration ≤ 50 IU/mL at screening

Exclusion Criteria

I do not have severe allergies to medications or the ingredients in GIGA-2339.

I haven't had live vaccines recently and won't have any soon.

Liver stiffness > 8 kilopascal (kPa) at screening

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Single Ascending Dose (SAD)

Participants receive a single IV infusion of either GIGA-2339 or placebo in ascending doses

1 day

1 visit (in-person)

Multiple Ascending Dose (MAD)

Participants receive multiple IV infusions of either GIGA-2339 or placebo, once every 4 weeks

Duration based on dose escalation

1 visit every 4 weeks (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• GIGA-2339

Trial Overview The study is testing the safety and how the body processes GIGA-2339 when given through an IV. Participants will receive either GIGA-2339 or a placebo in single or multiple doses to compare effects.

How Is the Trial Designed?

Group I: Part 2: Multiple Ascending Dose (MAD) Experimental Treatment 2 Interventions

Participants will receive multiple IV infusions of either GIGA-2339 or placebo, once every 4 weeks, at a dose determined in Part 1.

Group II: Part 1: Single Ascending Dose (SAD) Experimental Treatment 2 Interventions

Participants will receive a single IV infusion of either GIGA-2339 or placebo in ascending doses on Day 1.

Who Is Running the Clinical Trial?

GigaGen, Inc.

Lead Sponsor

Trials

2

Recruited

60+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07024641

NCT07024641 | A Study to Assess the Safety, Tolerability, ... The primary purpose of this study is to assess the safety and tolerability of single and multiple intravenous (IV) doses of GIGA-2339 in participants with ...

2. contagionlive.com contagionlive.com/view/gigagen-doses-first-patient-in-phase-1-trial-of-giga-2339-a-potential-functional-cure-for-chronic-hepatitis-b

GigaGen Doses First Patient in Phase 1 Trial of GIGA-2339 ... With its unique combination of potent, broad-acting antibodies and a potential to reactivate the immune system, GIGA-2339 could play a key role ...

3. clinicaltrialsarena.com clinicaltrialsarena.com/news/gigagen-phase-i-giga-2339/

GigaGen commences Phase I clinical trial of GIGA-2339 for ... The potency of GIGA-2339 is claimed to be more than 2,000 times greater than that of plasma-derived HBV treatments. November 20, 2024. Share.

4. grifols.com grifols.com/en/view-news/-/news/gigagen-doses-first-patient-in-phase-1-trial-of-recombinant-polyclonal-drug-candidate-giga-2339-for-hepatitis-b-virus

GigaGen Doses First Patient in Phase 1 Trial of ... GIGA-2339 is over 2,000 times more potent than plasma-derived HBV drugs and covers the large diversity of circulating HBV variants. In mouse ...

5. clinicaltrialvanguard.com clinicaltrialvanguard.com/executiveinterviews/exploring-the-future-of-hbv-treatment-with-gigagen-giga-2339/

Exploring The Future of HBV Treatment with GigaGen ... In our preclinical studies, GIGA-2339 has shown the ability to significantly reduce HBV surface antigen levels, a key marker of chronic ...

6. centerwatch.com centerwatch.com/clinical-trials/listings/NCT07024641/a-study-to-assess-the-safety-tolerability-and-pharmacokinetics-of-giga-2339-in-participants-with-chronic-hepatitis-b-virus-infection

A Study to Assess the Safety, Tolerability, and ... The primary purpose of this study is to assess the safety and tolerability of single and multiple intravenous (IV) doses of GIGA-2339 in ...