SUVN-I6107 Safety Study

Overseen By Ramakrishna Nirogi

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Suven Life Sciences Limited

Disqualifiers: Pregnancy, Lactation, Recent illness, others

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

Compensation: Varies

Number of Visits: Unknown

64 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called SUVN-I6107. Researchers aim to assess its safety and how the body processes it at various doses. They also examine the effects of food on the treatment and its impact on brain activity. Individuals willing to avoid caffeine and alcohol for a few days and with a body weight between 50 kg and 100 kg may be suitable for this trial. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive it.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is there any evidence suggesting that SUVN-I6107 is likely to be safe for humans?

Researchers continue to study the safety of SUVN-I6107 in humans. The main goal is to assess how well people tolerate different doses. They monitor for side effects and changes in blood tests, heart rate, and blood pressure.

Since SUVN-I6107 is in early testing stages, detailed safety information remains limited. At this stage, researchers test the treatment in a small group to identify any immediate safety concerns. They gather information to ensure it is safe enough for larger trials.

In summary, while detailed safety information is not yet available, the research focuses on ensuring SUVN-I6107's safety for human use. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

SUVN-I6107 is unique because, unlike current treatments for neurological conditions that often focus on symptom management, this investigational drug targets a novel mechanism potentially addressing the root causes of such disorders. Researchers are excited about SUVN-I6107 because it offers a fresh approach with its single and multiple ascending dose strategies, which might provide more flexibility and adaptability in dosing compared to standard treatments. This could lead to more personalized treatment plans and possibly faster therapeutic effects, providing new hope for patients who have limited options.

What evidence suggests that SUVN-I6107 could be effective?

Research has shown that SUVN-I6107 may improve memory and attention, based on animal studies. In this trial, participants will receive either single ascending doses or multiple ascending doses of SUVN-I6107 to evaluate its safety and effects. Although limited information exists from human studies, researchers are investigating how this treatment might affect brain activity. Early results examine how the drug is absorbed in the body and its effects on brain waves. This ongoing research aims to understand how SUVN-I6107 could work in people. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for healthy adults with normal blood and urine tests, a BMI of 18.0-30.0 kg/m2 (or up to 32.0 for part of the study), weighing between 50-100 kg, who can avoid alcohol, caffeine, and certain foods before each study visit. Pregnant or breastfeeding individuals or those planning pregnancy are excluded.

Inclusion Criteria

Ability and willingness to abstain from alcohol-, caffeine-, and methylxanthine-containing beverages or food from 48 hours prior to each admission to the clinical facility until study discharge

All values for hematology and clinical chemistry tests of blood and urine within the normal range or showing no clinically relevant deviations at screening and at admission

My BMI is between 18.0-30.0 for Segment 1 or 18.0-32.0 for Segment 2, and my weight is between 50-100 kg.

Exclusion Criteria

I am not pregnant, breastfeeding, planning to become pregnant, or donate eggs during or within 30 days after the study.

My partner is pregnant, breastfeeding, or might become pregnant during the study or within 3 months after.

I haven't had any major illnesses or surgeries in the last 4 weeks.

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 single ascending doses of SUVN-I6107 to assess safety, tolerability, and pharmacokinetics

11 days

Multiple visits for dosing and assessments

Multiple Ascending Dose (MAD)

Participants receive multiple ascending doses of SUVN-I6107 for 14 consecutive days to assess safety, tolerability, and pharmacokinetics

14 days

Daily visits for dosing and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

10 days

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• SUVN-I6107

Trial Overview The trial is testing SUVN-I6107's safety after one dose and over multiple doses in different amounts. It also looks at how the body processes it with and without food and its effects on brain activity measured by qEEG and ERP assessments.

How Is the Trial Designed?

Group I: Single Ascending Dose Experimental Treatment 2 Interventions

single ascending doses administered orally

Group II: Multiple Ascending Dose Experimental Treatment 2 Interventions

multiple ascending doses administered orally for 14 days.

Who Is Running the Clinical Trial?

Suven Life Sciences Limited

Lead Sponsor

Trials

14

Recruited

1,700+

Published Research Related to This Trial

The maximum tolerated dose (MTD) of E7107 was determined to be 4.0 mg/m², with dose-limiting toxicities primarily involving gastrointestinal issues such as grade 3 diarrhea and nausea in some patients.

Pharmacodynamic analysis showed that E7107 effectively inhibited pre-mRNA processing of target genes in a dose-dependent manner, indicating its potential clinical activity despite no complete or partial responses observed during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I pharmacokinetic and pharmacodynamic study of the first-in-class spliceosome inhibitor E7107 in patients with advanced solid tumors. Eskens, FA., Ramos, FJ., Burger, H., et al.[2022]

AMG 181 demonstrated favorable pharmacokinetics with a long half-life of approximately 31 days and high bioavailability (82%-99%) after subcutaneous administration, indicating it is well-absorbed and maintained in the body for an extended period.

In ulcerative colitis patients, AMG 181 led to remission and mucosal healing without serious adverse events, suggesting it is a safe and effective treatment option for inflammatory bowel diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical pharmacology of AMG 181, a gut-specific human anti-α4β7 monoclonal antibody, for treating inflammatory bowel diseases. Pan, WJ., Köck, K., Rees, WA., et al.[2021]

SPH3127 demonstrated a dose-dependent increase in exposure and effectively suppressed plasma renin activity by up to 90% for 24 hours, indicating its potential efficacy in managing conditions related to renin activity.

The drug was well tolerated among healthy individuals, with only mild adverse events reported in 29.2% of single-dose and 33.3% of multiple-dose participants, suggesting a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SPH3127: A Phase I, Randomized, Double-Blind, Placebo-Controlled Trial. Jing, S., Xu, R., Yang, K., et al.[2021]

Intravenous (IV) siponimod was found to be well tolerated in healthy subjects, with no significant effects on heart rate and similar safety profiles to oral siponimod, indicating its potential for safe use in clinical settings.

The pharmacokinetics showed that IV siponimod resulted in higher peak exposure compared to oral dosing, supporting the development of a rapid IV titration regimen for patients, particularly those with conditions like intracerebral hemorrhage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Intravenous Siponimod: A Randomized, Open-label Study in Healthy Subjects. Shakeri-Nejad, K., Gardin, A., Gray, C., et al.[2020]

The study found that auto-injector systems (A-INJ) effectively delivered both placebo and active injectates while maintaining blinding in randomized controlled trials, with no significant difference in delivery rates compared to conventional syringes.

Investigators reported no concerns about becoming unblinded when using the A-INJ, highlighting its potential to improve the integrity of clinical trials without the need for additional modifications to the placebo.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blinding Is Seeing: A Single-Centre Study Into the Viability of Auto-Injectors for Blinded-Drug Administration in Randomised Controlled Trials. Aggarwal, V., Taubel, J., Lorch, U., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06705088

Study Details | NCT06705088 | Safety, Tolerability, ... The purpose of this study is 1) to investigate how safe and tolerable SUVN-I6107 is after a single oral dose at increasing dose levels and multiple oral doses ...

2. clinicaltrialsarena.com clinicaltrialsarena.com/news/suven-first-suvn-i6107-cognitive/

Suven doses first subjects in trial of SUVN-I6107 for ... The Phase I study is a two-part, double-blind, randomised, placebo-controlled trial designed to evaluate single and multiple ascending oral ...

3. suven.com suven.com/pdf/SUVENPressRelease27082024.pdf

CSD/BSE&NSE/PR/2024-2025 Preclinical evidence has shown that treatment with SUVN-I6107 results in precognitive properties in diverse animal models. Additionally, SUVN-I ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06705088?term=AREA%5BConditionSearch%5D(Potassium-aggravated%20myotonia%20OR%20%22K-aggravated%20myotonia%22%20OR%20%22%20K%20-aggravated%20myotonia%22%20OR%20%22%20myotonia%20congenita,%20atypical,%20acetazolamide-responsive%22%20OR%20%22%20PAM%22%20OR%20%22%20Potassium%20aggravated%20myotonia%22)%20AND%20AREA%5BOverallStatus%5D(NOT_YET_RECRUITING%20OR%20RECRUITING)&rank=4

Study Details | NCT06705088 | Safety, Tolerability, ... The purpose of this study is 1) to investigate how safe and tolerable SUVN-I6107 is after a single oral dose at increasing dose levels and multiple oral doses ...

5. withpower.com withpower.com/trial/phase-1-healthy-subjects-hs-11-2024-76633

SUVN-I6107 Safety Study The purpose of this study is 1) to investigate how safe and tolerable SUVN-I6107 is after a single oral dose at increasing dose levels and multiple oral doses ...

6. expresspharma.in expresspharma.in/suven-life-sciences-announces-first-subjects-dosed-in-phase-1-clinical-trial-of-suvn-i6107-for-treating-cognitive-disorders/

Suven Life Sciences announces first subjects dosed in ... The study's primary objective is to assess the safety and tolerability of SUVN-I6107, a true muscarinic M1 positive allosteric modulator.