Trial reportDrug design, development and therapy2025
The Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Subcutaneous Administration of a Novel Anti-NGF Monoclonal Antibody (AK115) in Healthy Participants: A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Phase I Clinical Trial.
Trial report in Drug design, development and therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05286970 (A Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Characteristics of Single Dose Subcutaneous Administration of AK115 in Healthy Subjects), which is not on this map. Cited by 3 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Characteristics of Single Dose Subcutaneous Administration of AK115 in Healthy Subjects
Who cites it
3 citing papers in PubMed.
- Taming pet allergens: strategies to make furry cats less allergenic.Frontiers in allergy · 2026Review
- Possible Anti-Pain Vaccines: A Narrative Review of Emerging Strategies and Clinical Prospects.Vaccines · 2025Review
- Nerve growth factor: what can surgeons and oncologists learn from a neurological and psychological biomarker?Molecular medicine (Cambridge, Mass.) · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
14 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Objective: This study aimed to investigate the safety, tolerability, pharmacokinetics (PKs), and pharmacodynamics (PDs) of a novel anti-nerve growth factor (NGF) monoclonal antibody (mAb) (AK115) in healthy Chinese participants. Methods: A randomized, double-blind, placebo-controlled, dose-escalation phase I clinical study was conducted as follows: eligible participants were divided into 6 dose groups, among which 0.5 mg group was administrated with AK115 injection and the remaining 5 groups were randomly assigned to AK115 injection or accompanying placebo at a ratio of 3:1. Adverse events (AEs), PKs, PDs, and anti-drug antibodies (ADAs)/neutralizing antibody were monitored throughout the study. Results: A total of 42 participants completed the study. Twenty-seven (64.3%) participants occurred treatment emergent AEs (TEAEs), and 2 (4.80%) participants experienced treatment-related TEAEs. The TEAEs among the different dose groups were comparable. No significant differences were observed between the combined AK115 and the placebo group. It was demonstrated that the median T Conclusion: The favorable safety and tolerability of AK115 in healthy Chinese participants, as well as the predictable PK and PD profiles, will provide sufficient support for future dose exploration studies of AK115 in patients with analgesia. Trial Registration: This study was registered in the Chinese Clinical Trial Registry (CTR20220431) and the official website of the US Department of Health and Human Services, National Institutes of Health, with Clinical Trials. gov (NCT05286970) on March 2022.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.