A Phase 1 Study of Single and Multiple Intravenous Doses of SM17 in Healthy Subjects

Overseen By Angie Badgett, MBA

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: SinoMab BioScience Ltd

Must not be taking: Over-the-counter, Prescription, Herbal, Biologics

Disqualifiers: Diabetes, Cardiac disease, Hypertension, others

Compensation: Varies

Number of Visits: Unknown

77 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a new drug called SM17 given through an IV in healthy people. It aims to see if SM17 is safe and how the body processes it.

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

Yes, you will need to stop taking any over-the-counter or prescription medications at least 14 days before the first dose, unless specified otherwise in the protocol. Some exceptions like acetaminophen and hormone replacement therapy are allowed after the first dosing.

What safety data exists for placebo treatments?

Placebo treatments are often used in clinical trials to compare the effects of new treatments, but safety data for placebos themselves is not always well-reported. Studies show that safety information in trials is often neglected, with only a small percentage of trials adequately reporting adverse effects and reasons for withdrawal due to toxicity. ^{1 2 3 4 5}

How does the treatment Placebo, SM17 differ from other treatments?

The treatment Placebo, SM17 is unique because it serves as a control or dummy treatment, meaning it is used to compare the effects of an actual treatment in clinical trials. It does not contain active ingredients intended to treat the condition, unlike other treatments that aim to provide therapeutic benefits. ^{6 7 8 9 10}

Eligibility Criteria

Inclusion Criteria

Healthy, adult, male or female* (of non childbearing potential only), 19-55 years of age, inclusive, at the time of consent.

Females of non-childbearing potential are defined as follows:

- Females who have undergone one of the following sterilization procedures at least 6 months prior to the first dosing: Hysteroscopic sterilization, Bilateral tubal ligation or bilateral salpingectomy, Hysterectomy, Bilateral oophorectomy

Exclusion Criteria

Previously hospitalized for severe acute respiratory syndrome-coronavirus 2 (SARS Cov 2) prior to the screening visit.

History or evidence of a clinically significant disorder (including psychiatric), condition or disease that, in the opinion of the PI or designee would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.

Positive polymerase chain reaction test for SARS-CoV-2, either with the absence or presence of the clinical symptoms of COVID 19.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part A

Participants receive a single ascending dose of SM17 or placebo intravenously

0-4 weeks

Treatment Part B

Participants receive multiple ascending doses of SM17 or placebo intravenously

0-16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Placebo
• SM17

Participant Groups

Group I: Drug SM17 Experimental Treatment 1 Intervention

Peripheral intravenous injection

Group II: Drug Placebo Placebo Group 1 Intervention

Peripheral intravenous injection

Who Is Running the Clinical Trial?

SinoMab BioScience Ltd

Lead Sponsor

Trials

5

Recruited

830+

Findings from Research

A new checklist called TIDieR-Placebo has been developed to improve the reporting of placebo or sham interventions in clinical trials, ensuring that researchers clearly describe these components alongside active treatments.

The checklist was created through expert consultation and aims to enhance the transparency of trial results, which is crucial for accurately assessing the benefits and harms of active interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

TIDieR-Placebo: A guide and checklist for reporting placebo and sham controls. Howick, J., Webster, RK., Rees, JL., et al.[2020]

The study systematically analyzed placebo effects from randomized, placebo-controlled trials, revealing that while placebos can influence clinical symptoms, they do not affect laboratory values like blood glucose in diabetics.

Placebo side effects were found to be similar to those of active treatments, highlighting the importance of careful placebo use in clinical research to ensure patient safety and informed consent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Placebo treatment is effective differently in different diseases--but is it also harmless? A brief synopsis. Weihrauch, TR.[2019]

A review of 192 randomized clinical trials revealed that safety information is often underreported, with only 46% specifying reasons for withdrawals due to toxicity and only 39% adequately reporting clinical adverse effects.

To enhance safety reporting, the study emphasizes the need for standardized scales for adverse effects, systematic data collection, and detailed reporting of severe reactions, suggesting that improved practices could lead to better safety insights in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving safety reporting from randomised trials. Ioannidis, JP., Lau, J.[2018]

In a study involving 24 rabbits undergoing spine fusion, daily subcutaneous injections of abaloparatide resulted in a 100% fusion rate compared to only 45% in the control group, indicating its strong efficacy in promoting spinal fusion.

Radiographic analysis showed that abaloparatide significantly increased bone formation and quality, with higher bone volume and improved trabecular structure, suggesting it enhances the biological processes necessary for successful spinal fusion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Abaloparatide Enhances Fusion and Bone Formation in a Rabbit Spinal Arthrodesis Model. Morse, KW., Moore, H., Kumagai, H., et al.[2023]

In a study involving six competitive wheelchair athletes, short-term oral creatine supplementation did not significantly improve 800 m performance compared to a placebo, indicating that creatine may not enhance performance in this specific group.

All measured parameters, including completion time, perceived exertion, lactate levels, and heart rate, showed no significant differences between the creatine and placebo conditions, suggesting that creatine supplementation may not be effective for trained, spinal cord-injured athletes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of creatine supplementation on 800 m wheelchair performance: a pilot study. Perret, C., Mueller, G., Knecht, H.[2013]

The mouthrinse containing 0.05% CHX and 0.05% CPC significantly reduced plaque levels in patients with poor oral hygiene over a 3-month period, indicating its efficacy in improving oral health (P<0.001).

While the mouthrinse effectively decreased plaque and bleeding on probing, it did not show a significant impact on gingival inflammation or overall patient-reported outcomes, suggesting that while it helps with plaque control, it may not fully address all aspects of gum health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lower concentration of chlorhexidine and cetyl-pyridinium chloride mouthwash demonstrates some efficacy. Lamont, T.[2012]

In a study of 111 individuals with low back pain, patients in the control group were more accurately aware of their treatment assignment compared to those receiving active treatment (78% vs. 54%), indicating that the manual placebo did not effectively blind participants.

Despite the lack of successful blinding, both treatment groups showed significant improvement in pain disability, suggesting that factors beyond the specific biomechanical treatment may contribute to therapeutic outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized trial investigating a chiropractic manual placebo: a novel design using standardized forces in the delivery of active and control treatments. Hawk, C., Long, CR., Rowell, RM., et al.[2015]

References

1. United States pubmed.ncbi.nlm.nih.gov

TIDieR-Placebo: A guide and checklist for reporting placebo and sham controls. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Placebo treatment is effective differently in different diseases--but is it also harmless? A brief synopsis. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Does maintained spinal manipulation therapy for chronic nonspecific low back pain result in better long-term outcome? [2022]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Improving safety reporting from randomised trials. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

A Randomized, Double-blind, Placebo-Controlled Crossover Trial of Oxymorphone Hydrochloride and Propoxyphene/Acetaminophen Combination for the Treatment of Neurogenic Claudication Associated With Lumbar Spinal Stenosis. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Abaloparatide Enhances Fusion and Bone Formation in a Rabbit Spinal Arthrodesis Model. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Comparison of static and placebo magnets on resting forearm blood flow in young, healthy men. [2004]

8. England pubmed.ncbi.nlm.nih.gov

Influence of creatine supplementation on 800 m wheelchair performance: a pilot study. [2013]

9. England pubmed.ncbi.nlm.nih.gov

Lower concentration of chlorhexidine and cetyl-pyridinium chloride mouthwash demonstrates some efficacy. [2012]

10. United States pubmed.ncbi.nlm.nih.gov

A randomized trial investigating a chiropractic manual placebo: a novel design using standardized forces in the delivery of active and control treatments. [2015]